- Email: [email protected]
Quality of life evaluation after implantation of 2 multifocal intraocular lens models and a monofocal model
ARTICLE
Quality of life evaluation after implantation of 2 multifocal intraocular lens models and a monofocal model Jorge L. Ali o, MD, PhD, Ana B. Plaza-Puche, MSc, David P. Pi~ nero, PhD, Francisco Amparo, MD, Jose L. Rodríguez-Prats, MD, PhD, María Jose Ayala, MD
PURPOSE: To compare vision-related quality of life using the National Eye Institute Visual Function Questionnaire (NEI VFQ-25) in patients with 1 of 3 types of intraocular lenses (IOLs) and to correlate it with postoperative visual outcomes. SETTING: Vissum Corporation–Instituto Oftalmologico de Alicante, Alicante, Spain. DESIGN: Comparative case series. METHODS: This study comprised eyes having cataract surgery with bilateral implantation of a monofocal IOL (Group A), apodized multifocal IOL (Group B), or full diffractive multifocal IOL (Group C). Distance and near visual acuities, contrast sensitivity, and quality of life were evaluated preoperatively and postoperatively. RESULTS: The study enrolled 106 eyes (53 patients; age range 49 to 80 years). All groups had significant improvement in uncorrected and corrected distance visual acuities postoperatively (P%.05). Near vision outcomes were significantly better in Groups B and C (P%.01). Groups B and C had significantly less difficulty in some near tasks, such as reading the newspaper (A–B, PZ.02; A–C, PZ.02) or reading bills (A–B, PZ.04; A–C, PZ.004). Group C also had significantly less difficulty driving at night than Group B (P<.01). Near visual acuity and contrast sensitivity were significantly correlated with difficulty in near visual tasks in Groups B and C. Night-driving difficulty correlated significantly with contrast sensitivity in Group B. CONCLUSIONS: Patients with multifocal IOLs could perform several daily tasks at near and intermediate distances, with less night-driving limitation with the full diffractive IOL than with apodized multifocal and monofocal IOLs. Financial Disclosure: No author has a financial or proprietary interest in any material or method mentioned. J Cataract Refract Surg 2011; 37:638–648 Q 2011 ASCRS and ESCRS
The visual impairment caused by cataract can lead to a significant reduction in patients’ quality of life. Driving, reading, or performing other daily-life activities that depend on visual performance can become extremely difficult for these patients.1 The goal of modern cataract surgery is to achieve fast visual rehabilitation without complications and with low postoperative residual refractive errors,2 which would have a significant positive impact on the patient’s quality of life. New intraocular lens (IOL) designs aimed at restoring not only visual function at distance but also at near have been developed and introduced into clinical practice. This would theoretically provide complete 638
Q 2011 ASCRS and ESCRS Published by Elsevier Inc.
visual restoration, allowing the patient to successfully perform normal activities of daily living. Multifocal IOLs3 generate different foci in an attempt to solve the visual limitation at near and intermediate distances that occurs with classic monofocal IOLs. Indeed, multifocal IOLs have been shown to provide near and distance functional vision without the need for corrective lenses.4–10 Optical side effects, such as decreased contrast sensitivity, glare disability, and halos, have been reported with some multifocal IOL models.11–16 These effects can significantly affect the patient’s visual performance and thus the patient’s satisfaction and quality 0886-3350/$ - see front matter doi:10.1016/j.jcrs.2010.10.056
QUALITY OF LIFE AFTER MULTIFOCAL IOL IMPLANTATION
of life. Some patients with significant visual improvement after surgery are very dissatisfied with the outcomes because their expectations were not met or their postoperative visual quality is limited. For this reason, the visual acuity measure is not sufficient to confirm a successful outcome after cataract surgery.17–20 Vision-specific, health-related quality-oflife instruments can be used as complementary tools for evaluating the general outcomes of a specific modality of cataract surgery. They have been shown to be valid instruments to evaluate the functional impairment related to vision.21 The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) measures the selfreported, vision-targeted health status of people with chronic eye disease.22–24 This questionnaire measures the effect of visual disability and visual symptoms on general health, such as emotional well-being and social functioning. It also measures the extent to which the eye disease affects a patient’s ability to live without pain, work productively, and interact with loved ones.25 The NEI VFQ-25 has been used with people who are free of eye disease as well as with those who have a specific ocular pathology, such as agerelated macular degeneration, cataract, glaucoma, and Graves ophthalmopathy.23,25,26 It has also been used to evaluate subjective visual function changes after various intraocular procedures, such as cataract or macular hole surgery.27 Therefore, the NEI VFQ-25 is useful for measuring health-related quality of life in patients with various eye diseases and treatments. The aim of the current study was to compare the vision-related quality of life using the NEI VFQ 25 questionnaire in patients with 1 of 3 types of IOLsd 2 multifocal models and 1 monofocal modeldand to correlate it with postoperative visual outcomes.
Submitted: April 28, 2010. Final revision submitted: October 21, 2010. Accepted: October 22, 2010. From Vissum Corporation–Instituto Oftalmologico de Alicante (Ali o, Plaza-Puche, Pi~ nero, Amparo, Rodrıguez-Prats, Ayala), the Division of Ophthalmology (Alio), Universidad Miguel Hernandez, and the Departamento de Optica, Farmacologıa y Anatomıa ~ (Pinero), Universidad de Alicante, Alicante, Spain. Supported in part by a grant from the Spanish Ministry of Health, Instituto Carlos III, Red Tematica de Investigacion Cooperativa en Salud “Patologıa ocular del envejecimiento, calidad visual y calidad de vida,” Subproyecto de Calidad Visual (RD07/0062). Corresponding author: Jorge L. Alio, MD, PhD, Vissum Corporation–Instituto Oftalmol ogico de Alicante, Avenida de Denia s/n, Edificio Vissum, 03016 Alicante, Spain. E-mail: [email protected].
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PATIENTS AND METHODS Patients This prospective case series comprised eyes of bilateral cataract patients. All patients were adequately informed and signed a consent form. The study adhered to the tenets of the Declaration of Helsinki and was approved by the local ethical committee. The inclusion criteria were cataract (Lens Opacity Classification System III28: NO1, C1, P1, or more severity) causing a significant reduction in visual quality, older than 45 years, and a minimum education level (reading ability). The exclusion criteria were active ocular disease and astigmatism higher than 3.00 diopters. Cataract patients who came to Vissum Instituto Oftalmol ogico de Alicante for consultation were randomized to receive bilateral implantation of 1 of the 3 IOL models using random-number sequence software. All patients received the same IOL model in both eyes (ie, no mix and match).
Surgical Technique All surgeries were performed by 1 of 3 experienced surgeons (J.L.A, J.L.R-P., J.J.) using the same standard technique of sutureless microincision phacoemulsification and the same protocol. All patients received topical anesthesia before surgery. Adequate dilation was obtained with intracameral mydriasis. The incision was placed on the axis of the positive corneal meridian. After the microincision was created, the incision was enlarged to approximately 3.0 mm for IOL implantation. Postoperative topical therapy included a combination of topical antibiotic and steroidal agents.
Intraocular Lenses The monofocal IOL in this study was the Acri.Smart 48S (Carl Zeiss Meditec AG). This single-piece spherical foldable acrylic IOL has a 25% water content in its fully hydrated state and hydrophobic surfaces.29 It has a biconvex–equiconvex 5.5 mm optic with a total diameter of 11.0 mm. Patients with this IOL were assigned to Group A. One of the multifocal IOLs in this study was the AcrySof ReSTOR SN6AD3 (Alcon Laboratories, Inc.), which is designed to provide quality near to distance vision by combining apodized diffractive and refractive technologies.8,9,13,30–32 The center of the IOL surface consists of an apodized diffractive optic (3.6 mm diameter) that focuses light for near through distance. The refractive region of the IOL bends light as it passes through the IOL to a focal point on the retina. This outer ring of the IOL surrounds the apodized diffractive region and is dedicated to focusing light for distance vision.8,9,13,30–32 Patients with this IOL were assigned to Group B. The other multifocal IOL in this study was the Acri.LISA 366D (Carl Zeiss Meditec AG), which is an aspheric bifocal biconvex refractive–diffractive design.5 This single-piece IOL has an optic diameter of 6.0 mm and an overall diameter of 11.0 mm. The surface is divided into main zones and phase zones; the phase zones assume the function of the steps of diffractive IOLs and have a mean refractive power corresponding to the zero diffractive power of the main zones. The incident light is distributed with 65% to distance focus and 35% to near focus.5 Patients with this IOL were assigned to Group C.
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Preoperative Examination Preoperatively, all patients had a full ophthalmologic examination including evaluation of the subjective refractive status, distance and near visual acuities, anterior segment evaluation at the slitlamp, tonometry (Goldmann tonometer), and indirect fundoscopy. Distance visual acuity was measured with Snellen charts and near visual acuity, with Radner Reading Charts.33 The Salzburg Reading Desk34 was used to measure binocular near visual acuity. The Salzburg Reading Desk consists of a sophisticated reading desk with 2 high-frequency repro lights, a constant illuminance level of 500 lux, 2 video cameras measuring the reading distance by stereo photometry, and a reading board with a variable angle (0 to 40 degrees). This desk allows measurement of reading time, distance, acuity, and speed using Radner Reading Charts as well as the angulation of the reading board. Other examinations were corneal topography (Costruzione Strumenti Oftalmici), biometry (IOLMaster, Carl Zeiss Meditec AG), and contrast sensitivity (CST 1800, Vision Science Research Corp.) under photopic conditions (85 candelas [cd]/m2) and low mesopic conditions (3 cd/m2). Quality of life was evaluated using of the NEI VFQ-25 questionnaire with the appendix NEI VFQ-39. The NEI VFQ-2524,35 consists of 25 items and a supplement of 14 additional items, all of which were taken from the original 52-item NEI VFQ. Among the 39 items of the NEI VFQ-25 plus supplement, 6 ask patients to grade their general health and vision, 20 rate difficulties with activities, and 13 ask about the level of agreement with statements describing the severity of problems associated with vision loss. The questions on difficulty with activities were rated on a scale of 1 to 6, with response choices including no difficulty, a little difficulty, moderate difficulty, extreme difficulty, stopped doing this because of your eyesight, and stopped doing this for other reasons/not interested. A rating response of 6 was scored as missing data. The questions on the level of agreement with statements describing role limitations due to vision loss were rated on a 5-point scale, ranging from agree all of the time to agree none of the time for 5 of the items and ranging from definitely true to definitely false for the remaining 8 items. Two items in the supplement rated overall health and vision on a 0 (worst) to 10 (best) scale. In addition, patients were asked about their ability to perform tasks under usual conditions with correction (if needed) or without correction. Patients were not asked about their ability to perform task without correction only.
Postoperative Examination Patients were evaluated postoperatively at 1 day and 1 and 3 months. The postoperative examination protocol at 1 month and 3 months was identical to the preoperative protocol.
Statistical Analysis Statistical analysis was performed using SPSS for Windows software (version 15.0.1, SPSS, Inc.). The mean values and standard deviations were calculated for every parameter. Normality of all data samples was first checked using the Kolmogorov-Smirnov test. When parametric analysis was possible, 1-way analysis of variance with Bonferroni post hoc comparison was used to compare results between the 3 IOL groups. If variances were not homogeneous
(checked by the Levene test), Tamhane post hoc analysis was used. In all cases, a P value less than 0.05 was considered statistically significant. When parametric analysis was not possible, the Kruskal-Wallis test was used to compare the IOL groups using the same level of significance (P!.05). For post hoc analysis, the Mann-Whitney test with the Bonferroni adjustment was used to avoid the experimental error rate. In addition, correlation coefficients (Pearson or Spearman depending on whether normality condition could be assumed) were used to assess the correlation between variables.
RESULTS The study enrolled 106 eyes of 53 patients. Group A comprised 26 eyes; Group B, 38 eyes; and Group C, 42 eyes. Table 1 shows the preoperative data by IOL group. There were no statistically significant differences in age (PZ.11), axial length (PZ.16), or manifest cylinder (PZ.15) between the 3 groups. There were also no significant differences preoperatively between groups in any item on the quality-of-life questionnaire (PR.08). There were statistically significant differences in sphere between the groups (PZ.02), with a trend toward more preoperative myopia in Group C. Although there were no statistically significant differences in binocular logRAD uncorrected near visual acuity (UNVA) between groups (PZ.56), statistically significant differences were found in binocular logRAD corrected near visual acuity (CNVA) (PZ.03). Visual Acuity and Refraction Table 2 shows a comparative analysis of the visual and refractive outcomes and other clinical findings 3 months postoperatively. There were no statistically significant differences in manifest sphere or cylinder between the 3 IOL groups (PR.050). There were also no statistically significant differences in distance visual acuities (PR.11). The binocular logRAD was significantly better in eyes with multifocal IOLs (all P %.01). The difference between groups in binocular logRAD CNVA was at the limit of statistical significance (PZ.05), with the best mean outcome in Group C. Contrast Sensitivity Preoperatively, there was no statistically significant difference in contrast sensitivity outcomes at any spatial frequency between groups (PR.19). However, postoperative photopic contrast sensitivity was significantly better at spatial frequencies of 3, 6, and 18 cycles per degree (cpd) in the monofocal IOL group (3 cpd: Group A versus Group B, PZ.01; Group A versus Group C, PZ.03; Group B versus Group C, PZ.73) (6 cpd: PZ.01, PZ.01, and PZ.27, respectively) (18 cpd: P!.01, P!.01, and PZ.06, respectively). The contrast sensitivity at 12 cpd under photopic conditions
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Table 1. Comparison of the preoperative patient data by group.
Parameter Age (y) Mean G SD Range Median UDVA (logMAR) Monocular Mean G SD Range Median Binocular Mean G SD Range Median Sphere (D) Mean G SD Range Median Cylinder (D) Mean G SD Range Median CDVA (logMAR) Monocular Mean G SD Range Median Binocular Mean G SD Range Median UNVA (logRAD) Mean G SD Range Median CNVA (logRAD) Mean G SD Range Median IOP (mm Hg) Mean G SD Range Median AL (mm) Mean G SD Range Median
Group A (Monofocal IOL)
Group B (Apodized IOL)
Group C (Full Diffractive IOL)
65.62 G 8.93 51, 78 69.00
63.16 G 8.93 49, 80 64.00
59.09 G 8.79 50, 77 56.00
1.12 G 0.69 0.00, 2.00 0.13 0.92 G 0.60 0.30, 2.00 0.70 0.13 G 4.71 10.75, C7.75 0.00 1.07 G 0.86 3.00, 0.00 1.00
0.63 G 0.40 0.10, 1.52 0.20 0.48 G 0.38 0.00, 1.30 0.49
P Value Post Hoc Comparison P Value
A–B
A–C
B–C
.11*
.99
.13
.46
!.01†
!.01
!.01
.80
.02†
.01
.01
.71
!.01†
.07
!.01
.02
.15†
.11
.07
.80
!.01†
.02
!.01
.02
!.01†
!.01
!.01
.67
.57†
.32
.39
.86
.03†
!.01
!.01
.68
.20†
.40
.42
.08
.16z
.38
.21
.99
0.60 G 0.38 0.00, 1.78 0.22 0.48 G 0.31 0.00, 1.00 0.52
C1.19 G 2.31 4.50, C5.50 C2.50
C2.57 G 2.46 5.50, C8.00 C1.75
0.78 G 0.65 2.50, 0.00 0.75
0.73 G 0.62 2.50, 0.00 0.62
0.22 G 0.24 0.08, 1.00 0.22
0.10 G 0.13 0.00, 0.44 0.05
0.04 G 0.09 0.00, 0.40 0.00
0.20 G 0.04 0.08, 0.40 0.30
0.03 G 0.07 0.00, 0.22 0.00
0.02 G 0.05 0.0, 0.22 0.00
0.60 G 0.28 0.26, 1.05 0.53
0.65 G 0.22 0.13, 0.95 0.70
0.66 G 0.20 0.30, 0.91 0.73
0.28 G 0.19 0.07, 0.65 0.24
0.15 G 0.17 0.07, 0.66 0.12
0.13 G 0.11 0.04, 0.34 0.12
15.54 G 2.03 12, 19 15.00
16.21 G 2.79 11, 22 16.00
15.00 G 2.72 9, 21 15.50
23.47 G 1.58 20.77, 27.21 23.46
22.99 G 1.16 20.85, 25.69 23.08
22.90 G 1.14 20.62, 25.09 22.81
AL Z axial length; CDVA Z corrected distance visual acuity; CNVA Z binocular corrected near visual acuity; IOL Z intraocular lens; IOP Z intraocular pressure; UDVA Z uncorrected distance visual acuity; UNVA Z binocular uncorrected near visual acuity *Analysis of variance † Kruskal-Wallis z One-way analysis of variance
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Table 2. Comparison of the 3-month postoperative data by group. P Value Post Hoc Comparison Parameter UDVA (logMAR) Monocular Mean G SD Range Median Binocular Mean G SD Range Median Sphere (D) Mean G SD Range Median Cylinder (D) Mean G SD Range Median CDVA (logMAR) Monocular Mean G SD Range Median Binocular Mean G SD Range Median UNVA (logRAD) Mean G SD Range Median CNVA (logRAD) Mean G SD Range Median
Group A
Group B
Group C
0.09 G 0.14 0.00, 0.52 0.03
0.13 G 0.13 0.00, 0.40 0.10
0.10 G 0.11 0.00, 0.52 0.08
0.03 G 0.06 0.00, 0.15 0.00
0.05 G 0.08 0.00, 0.30 0.00
0.05 G 0.10 0.00, 0.40 0.00
0.08 G 0.45 1.00, C0.50 0.00
C0.36 G 0.48 0.50, C1.50 C0.50
C0.15 G 0.55 1.25, C1.50 0.00
0.63 G 0.44 2.00, 0.00 0.50
0.63 G 0.44 2.00, 0.00 0.75
0.53 G 0.38 1.25, 0.00 0.50
0.02 G 0.05 0.00, 0.15 0.00
0.02 G 0.03 0.00, 0.10 0.00
0.01 G 0.03 0.04, 0.12 0.00
0.02 G 0.04 0.00, 0.13 0.00
G0.02 0.00, 0.08 0.00
0.00 G 0.03 0.04, 0.10 0.00
0.47 G 0.22 0.15, 0.87 0.48
0.28 G 0.04 0.11, 0.77 0.18
0.19 G 0.08 0.07, 0.37 0.17
0.24 G 0.19 0.02, 0.69 0.21
0.21 G 0.14 0.01, 0.46 0.17
0.15 G 0.01 0.02, 0.27 0.15
P Value
A–B
A–C
B–C
!.01†
!.01
!.01
.80
.49*
.01
.37
.67
.09
.26
.15
.66*
.48
.88
.39
.11*
.39
.32
.12
.24*
.12
.16
.93
!.01*
!.01
!.01
.20
.21*/.051†
!.01
.99
.29
.050*/.01
CDVA Z corrected distance visual acuity; CNVA Z binocular corrected near visual acuity; UDVA Z uncorrected distance visual acuity; UNVA Z binocular uncorrected near visual acuity *Kruskal-Wallis † One-way analysis of variance
was significantly better in Group A (Group A versus Group B, PZ.02; Group A versus Group C, PZ.20; Group B versus Group C, PZ.04). Contrast sensitivity under mesopic conditions was significantly better at 6 cpd and 18 cpd in Group A (6 cpd: Group A versus Group B, PZ.02; Group A versus Group C, PZ.08) (18 cpd: PZ.01 and PZ.02, respectively) (Figure 1). Quality-of-Life Outcomes Postoperatively, Groups B and C had significantly less difficulty than Group A in reading the newspaper
and bills (P%.04) (Figure 2, A and B). Groups B and C had significantly less difficulty than Group A performing hobbies that required near vision (P%.01) (Figure 2, C). There were no statistically significant differences between Group B and Group C in these 3 areas (PR.28). In addition, Group C had significantly less difficulty driving at night than Group B (PZ.01); however, there were no significant differences in this parameter between Group A and Group B (PZ.14) or between Group A and Group C (PZ.74) (Figure 2, D). The scores for difficulty under night-driving conditions were lower in Group A than in Group C,
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Figure 1. Mean contrast sensitivity function by IOL group under photopic and mesopic low conditions (cd Z candelas; cpd Z cycles per degreee; CS Z contrast sensitivity; CSF Z contrast sensitivity function).
although the difference did not reach statistical significance. The difference in sample sizes could have accounted for this lack of significance, despite the trend. There were no statistically significant correlations between quality-of-life items and the clinical data in Group A. Tables 3 and 4 show the statistically significant correlations between different quality-of-life items and clinical parameters in Group B and Group C, respectively. Significant correlations were found between some visual acuity and contrast sensitivity parameters and the subjective perception of quality of vision and difficulty reading. In addition, there were several significant correlations between contrast sensitivity and different types of driving conditions in Group C. Complications No complications occurred intraoperatively or postoperatively. No case of capsule opacification was detected during the 3-month follow-up. DISCUSSION Intraocular lenses represent one of the major landmarks of the correction of aphakia after cataract surgery. Since Ridley invented IOLs in the 1950s,36 several improvements in their design and materials
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have been introduced, including the development of models to correct presbyopia. In the past several years, multifocal IOLs have been introduced into clinical practice with the aim of improving near vision and reducing dependence on reading glasses.4 However, visual quality problems have been described with some multifocal models,6,14,37–39 and these can limit their potential benefit. Specifically, diffractive IOLs have been associated with photic phenomena such as glare or halos.14,37 These optical side effects can negatively affect daily-life activities, limiting the patient’s ability to perform them and thus affecting the patient’s quality of life.40 The aim of the current study was to evaluate the quality of life with a validated questionnaire in patients with bilateral implantation of a standard monofocal IOL (Acri.Smart 48S), an apodized multifocal IOL (AcrySof ReSTOR SN6AD3), or a full diffractive IOL (Acri.LISA 366D). Both multifocal IOL models have an aspheric design to reduce the unwanted visual phenomena normally associated with other multifocal IOL designs and to increase the range of focus, improving retinal image quality.41 Previous studies42–45 show that aspheric optics provide better contrast sensitivity than spherical optics. As expected, there was significant improvement in distance vision postoperatively in all 3 IOL groups. This is consistent with findings in other studies.5,8,18,31,37,46 The uncorrected and corrected distance visual acuities were similar in the 3 groups. There was a significant improvement in UNVA and distancecorrected near visual acuity in all groups, as reported in previous studies.7,8,18,29,31,37,47 However, the 2 multifocal IOLs provided better near vision than the monofocal IOL, confirming the efficacy of these 2 models in restoring near visual function. This was expected because previous studies16,48–51 report better near visual performance with multifocal IOLs than with monofocal IOLs. Regarding postoperative contrast sensitivity, higher mean contrast sensitivity values were observed in eyes with the monofocal IOL, with statistically significant differences between all 3 groups in contrast sensitivity values under photopic conditions at all spatial frequencies analyzed. This is consistent with results in previous studies8,48,51 in which monofocal IOLs provided better contrast sensitivity outcomes than multifocal IOLs. There is a compromise between optical quality and near visual performance with multifocal IOLs; that is, the better the near vision, the more significant the aberrometric or scattering components. We evaluated the patients’ quality of life using the Spanish version of a validated questionnaire, the NEI VFQ-25.52 This questionnaire was initially developed to evaluate the visual impact of ocular pathology
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Figure 2. Differences in quality-of-life items between the 3 IOL groups. The boxes represent the 25% to 75% range; the thick black lines, the median; the whiskers, the highest and lowest values that were not outliers or extreme values; the circle, an outlier (value between 1.5 and 3.0 times the interquartile range); and the asterisks, extreme values (values more than 3 times the interquartile range).
on daily tasks and the quality of life.23–26 Several studies24,53–55 show the questionnaire to be reliable and valid for people with different visual acuity levels and conditions. To our knowledge, this is the first study to evaluate and compare the quality of life in patients with the 3 IOL models we used. As expected, patients with the multifocal IOLs had less difficulty performing near tasks, such as reading. In addition, these patients achieved significantly better postoperative near visual outcomes. This is consistent with findings in previous studies that showed an improvement in near tasks with other multifocal IOL models.9,40,56–58 Patients with the Acri.LISA 366D IOL reported less difficulty driving at night than patients with the hybrid AcrySof ReSTOR SN6AD3 IOL. Photic phenomena have been reported to be more frequent in eyes with multifocal IOLs, and these phenomena could negatively affect night driving.39
Choi and Schwiegerling59 performed simulations in a model eye with different IOL designs and found fewer stray-light artifacts under scotopic conditions in eyes with AcrySof ReSTOR multifocal IOLs than in eyes with full refractive or diffractive IOLs. The authors state that aspheric multifocal IOLs would provide some visual benefit by minimizing ocular aberrations, which may be the reason for our findings. Both multifocal IOL models in our study have an aspheric profile with the aim of providing better contrast sensitivity function as a result of less induction of aberrations; however, the aspheric profile of the 2 IOL models seems to be different (ie, different Q factor). Complete knowledge of all details of the design of these 2 IOL models is necessary to determine the exact reason for our findings. We did not measure the pupil size in this study. By doing so, it would have allowed us to provide a more
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Table 3. Correlations between quality-of-life items and visual parameters 3 months postoperatively in Group B. Quality-of-Life Item General health (1 Z excellent, 5 Z bad) General vision (1 Z Worst, 10 Z best) Difficulty reading (1 Z no difficulty, 5 Z extreme difficulty)
Correlation 1
Correlation 2
Correlation 3
Cylinder r Z 0.781; P!.01 Binocular at UDVA r Z 0.693, PZ0.04 Photopic CSF at 12 cpd r Z 0.913, PZ.03
d
d
Photopic CSF at 18 cpd r Z .892, PZ.04 Binocular UNVA r Z 0.822, PZ.007
d Binocular CNVA r Z 0.822, PZ.007
CNVA Z corrected near visual acuity (logRAD); cpd Z cycles per degree; CSF Z contrast sensitivity function; UDVA Z uncorrected distance visual acuity; UNVA Z uncorrected near visual acuity (logRAD)
complete report of the outcomes. This can be considered a limitation of the study but not a source of bias in the interpretation of outcomes. The 3 IOL groups had a similar age (age and pupil size are related60), and theoretically, none of the 3 IOLs is dependent on pupil size. Our research group found some years ago that pupil size had little effect on intraocular aberrations in eyes with AcrySof ReSTOR IOLs.61 Another potential limitation of our study is the inclusion of data from different surgeons. However, all surgeons used the same surgical protocol, which should have minimized the role of the surgeon factor in the variability in outcomes. Finally, correlations between quality of life and clinical data were evaluated. As expected, we found statistically significant correlations with difficulties in some near and intermediate visual tasks (eg, between reading the newspaper and near visual acuity) in the 2 multifocal IOL groups. These difficulties were also
significantly correlated with contrast sensitivity in the 2 groups. Based on these findings, the optical degradation in eyes with a multifocal IOL seemed to induce deterioration not only in distance vision but also in near vision, a finding that has been reported with other multifocal IOLs.14 Furthermore, there was an inverse significant correlation between difficulty driving at night and contrast sensitivity in eyes with the hybrid IOL, suggesting that this design is more likely to induce night-driving problems when contrast sensitivity is affected (eg, high IOL power, slight IOL decentration). These trends should be confirmed and validated in future studies. Quality of life is a multifactorial process and is not dependent on visual performance only. Some studies of different IOLs22,62 found no significant change in quality of life indices (using normalized questionnaires) despite improvement in certain clinical parameters. Thus, we avoided the use of general quality-of-life
Table 4. Correlations between quality-of-life items and visual parameters 3 months postoperatively in Group C. Quality-of-Life Item General vision (1 Z Worst, 10 Z best) Difficulty reading (1 Z no difficulty, 5 Z extreme difficulty) Difficulty reading bills (1 Z no difficulty, 5 Z extreme difficulty) Difficulty in general vision (1 Z no difficulty, 5 Z extreme difficulty) Difficulty going to cinema (1 Z no difficulty, 5 Z extreme difficulty) Difficulty driving (1 Z no difficulty, 5 Z extreme difficulty) Difficulty driving at night (1 Z no difficulty, 5 Z extreme difficulty) Difficulty driving in difficult conditions (1 Z no difficulty, 5 Z extreme difficulty)
Correlation 1
Correlation 2
Correlation 3
Binocular UDVA r Z 0.571, PZ.01 Sphere r Z 0.496, PZ.03 Sphere r Z 0.496, PZ.03 Binocular CDVA r Z 0.513, PZ.04 Binocular CDVA r Z 0.540, PZ.02 Scotopic CSF at 6 cpd r Z 0.615, PZ.01 Scotopic CSF at 6 cpd r Z 0.632, PZ.009 Scotopic CSF at 6 cpd r Z 0.646, PZ.007
Binocular CDVA r Z 0.585, PZ.01 Binocular CDVA r Z 0.554, PZ.02 d
d Binocular CNVA r Z 0.591, PZ.02 d
d
d
d
d
d
d
d
d
d
d
CDVA Z corrected distance visual acuity; CNVA Z corrected near visual acuity (logRAD); cpd Z cycles per degree; CSF Z contrast sensitivity function; UDVA Z uncorrected distance visual acuity
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indices (eg, Do you feel depressed? Are you happy?) and centered our analysis on those with a theoretical relationship to vision. One drawback of our study is the limitation of the randomization process. The number of eyes in the 3 groups differed; thus, we cannot make generalized conclusions that would be valid for the entire population. Larger numbers of cases would have been required for to make such conclusions. Furthermore, the asymmetric distribution could have been the cause of the borderline results we observed, such as the P value of 0.051 for the difference between groups in binocular logRAD CNVA. Therefore, more research is required to ascertain and specify with accuracy the complete impact on the quality of life of new IOL models for cataract surgery. Other types of IOLs should be included in this type of analysis. In summary, results indicate that AcrySof ReSTOR SN6AD3 and the Acri.LISA 366 D multifocal IOLs can restore near visual function after cataract surgery, allowing the patient to perform several daily tasks at near and intermediate distances and thus providing spectacle independence. The aspheric diffractive IOL (Acri.LISA 366D) provided the least limitation in night-driving performance. However, difficulty in night driving was significantly dependent on contrast sensitivity with the aspheric hybrid model (AcrySof ReSTOR SN6AD3). Furthermore, the monofocal IOLs provided distance visual restoration with a limited impact on near vision; it provided acceptable night-driving performance. Future research focused on establishing the exact relationship between quality of life and ocular optical quality is required to understand the problems reported by patients with different IOL models. REFERENCES
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38. Walkow L, Klemen UM. Patient satisfaction after implantation of diffractive designed multifocal intraocular lenses in dependence on objective parameters. Graefes Arch Clin Exp Ophthalmol 2001; 239:683–687. Available at: http://www.springerlink.com/content/ rcymcjmeqtugbgx5/fulltext.pdf. Accessed November 17, 2010 39. Dick HB, Krummenauer F, Schwenn O, Krist R, Pfeiffer N. Objective and subjective evaluation of photic phenomena after monofocal and multifocal intraocular lens implantation. Ophthalmology 1999; 106:1878–1886 40. Javitt JC, Steinert RF. Cataract extraction with multifocal intraocular lens implantation; a multinational clinical trial evaluating clinical, functional, and quality-of-life outcomes. Ophthalmology 2000; 107:2040–2048 ndez-Vega L, Amhaz H, Monte s-Mico R, 41. Alfonso JF, Ferna rcel B, Ferrer-Blasco T. Visual function after implantation Valca of an aspheric bifocal intraocular lens. J Cataract Refract Surg 2009; 35:885–892 ne fices 42. Denoyer A, Halfon J, Majzoub S, Pisella P-J. Quels be rique visuels peut-on attendre d’un implant sans aberration sphe dans la chirurgie de la cataracte? [Visual function after cataract surgery in patients with an aspherical lens without spherical aberration]. J Fr Ophtalmol 2007; 30:578–584. Available at: http://www.em-consulte.com/showarticlefile/113492/index.pdf. Accessed November 17, 2010 s K, 43. Rocha KM, Soriano ES, Chalita MR, Yamada AC, Botto s J, Morimoto L, Nose W. Wavefront analysis and contrast Botto sensitivity of aspheric and spherical intraocular lenses: a randomized prospective study. Am J Ophthalmol 2006; 142: 750–756 ~ oz G, Albarra n-Diego C, Monte s-Mico R, Rodrıguez44. Mun JL. Spherical aberration and contrast sensitivity Galietero A, Alio after cataract surgery with the Tecnis Z9000 intraocular lens. J Cataract Refract Surg 2006; 32:1320–1327 45. Bellucci R, Scialdone A, Buratto L, Morselli S, Chierego C, Criscuoli A, Moretti G, Piers P. Visual acuity and contrast sensitivity comparison between Tecnis and AcrySof SA60AT intraocular lenses: a multicenter randomized study. J Cataract Refract Surg 2005; 31:712–717; errata, 1857 JL, Elkady B, Ortiz D, Bernabeu G. Microincision multifocal 46. Alio intraocular lens with and without a capsular tension ring: optical quality and clinical outcomes. J Cataract Refract Surg 2008; 34:1468–1475 47. Tzelikis PF, Akaishi L, Trindade FC, Boteon JE. Ocular aberrations and contrast sensitivity after cataract surgery with AcrySof IQ intraocular lens implantation; clinical comparative study. J Cataract Refract Surg 2007; 33:1918–1924 48. Zeng M, Liu Y, Liu X, Yuan Z, Luo L, Xia Y, Zeng Y. Aberration and contrast sensitivity comparison of aspherical and monofocal and multifocal intraocular lens eyes. Clin Exp Ophthalmol 2007; 35:355–360 49. Steinert RF, Post CT Jr, Brint SF, Fritch CD, Hall DL, Wilder LW, Fine IH, Lichtenstein SB, Masket S, Casebeer C, Oksman H. A prospective, randomized, double-masked comparison of a zonal-progressive multifocal intraocular lens and a monofocal intraocular lens. Ophthalmology 1992; 99:853–860; discussion by JT Holladay, 860–861 50. Vingolo EM, Grenga P, Iacobelli L, Grenga R. Visual acuity and contrast sensitivity; AcrySof ReSTOR apodized diffractive versus AcrySof SA60AT monofocal intraocular lenses. J Cataract Refract Surg 2007; 33:1244–1247 51. Rocha KM, Chalita MR, B Souza CE, Soriano ES, Freitas LL, Muccioli C, Belfort R Jr. Postoperative wavefront analysis and contrast sensitivity of a multifocal apodized diffractive IOL (ReSTOR) and three monofocal IOLs. J Refract Surg 2005; 21:S808–S812
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n JL, Hays RD. Psychometric 52. Baker RS, Bazargan M, Caldero performance of the National Eye Institute visual function questionnaire in Latinos and non-Latinos. Ophthalmology 2006; 113:1363–1371 53. Globe D, Varma R, Azen SP, Paz S, Yu E, Preston-Martin S; and the Los Angeles Latino Eye Study Group. Psychometric performance of the NEI VFQ-25 in visually normal Latinos: the Los Angeles Latino Eye Study. Invest Ophthalmol Vis Sci 2003; 44:1470–1478. Available at: http://www.iovs.org/content/44/4/ 1470.full.pdf. Accessed November 17, 2010 54. Nichols KK, Mitchell GL, Zadnik K. Performance and repeatability of the NEI-VFQ-25 in patients with dry eye. Cornea 2002; 21:578–583 55. Broman AT, Munoz B, West SK, Rodriguez J, Sanchez R, Snyder R, Klein R. Psychometric properties of the 25-item NEI-VFQ in a Hispanic population: Proyecto VER. Invest Ophthalmol Vis Sci 2001; 42:606–613. Available at: http://www. iovs.org/content/42/3/606.full.pdf 56. Lehmann R, Waycaster C, Hileman K. A comparison of patientreported outcomes from an apodized diffractive intraocular lens and a conventional monofocal intraocular lens. Curr Med Res Opin 2006; 22:2591–2602 57. Javitt J, Brauweiler H-P, Jacobi KW, Klemen U, Kohnen S, €etzsch D. CataQuentin C-D, Teping C, Pham T, Knorz MC, Po ract extraction with multifocal intraocular lens implantation: clinical, functional, and quality-of-life outcomes; multicenter clinical trial in Germany and Austria. J Cataract Refract Surg 2000; 26:1356–1366
58. Javitt JC, Wang F, Trentacost DJ, Rowe M, Tarantino N. Outcomes of cataract extraction with multifocal intraocular lens implantation; functional status and quality of life. Ophthalmology 1997; 104:589–599 59. Choi J, Schwiegerling J. Optical performance measurement and night driving simulation of ReSTOR, ReZoom, and Tecnis multifocal intraocular lenses in a model eye. J Refract Surg 2008; 24:218–222 sio R Jr, Wilson SE. Pupil size in refractive 60. Netto MV, Ambro surgery candidates. J Refract Surg 2004; 20:337–342 JL, Bernabe u G, Pongo V. Optical performance of 61. Ortiz D, Alio monofocal and multifocal intraocular lenses in the human eye. J Cataract Refract Surg 2008; 34:755–762 62. The Moorfields IOL Study Group. Binocular implantation of the Tecnis Z9000 or AcrySof MA60AC intraocular lens in routine cataract surgery; prospective randomized controlled trial comparing VF-14 scores. J Cataract Refract Surg 2007; 33: 1559–1564
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First author: Jorge L. Ali o, MD, PhD Vissum Corporation-Instituto Oftalmologico Alicante, Alicante, Spain
Quality of life evaluation after implantation of 2 multifocal intraocular lens models and a monofocal model Jorge L. Ali o, MD, PhD, Ana B. Plaza-Puche, MSc, David P. Pi~ nero, PhD, Francisco Amparo, MD, Jose L. Rodríguez-Prats, MD, PhD, María Jose Ayala, MD
PURPOSE: To compare vision-related quality of life using the National Eye Institute Visual Function Questionnaire (NEI VFQ-25) in patients with 1 of 3 types of intraocular lenses (IOLs) and to correlate it with postoperative visual outcomes. SETTING: Vissum Corporation–Instituto Oftalmologico de Alicante, Alicante, Spain. DESIGN: Comparative case series. METHODS: This study comprised eyes having cataract surgery with bilateral implantation of a monofocal IOL (Group A), apodized multifocal IOL (Group B), or full diffractive multifocal IOL (Group C). Distance and near visual acuities, contrast sensitivity, and quality of life were evaluated preoperatively and postoperatively. RESULTS: The study enrolled 106 eyes (53 patients; age range 49 to 80 years). All groups had significant improvement in uncorrected and corrected distance visual acuities postoperatively (P%.05). Near vision outcomes were significantly better in Groups B and C (P%.01). Groups B and C had significantly less difficulty in some near tasks, such as reading the newspaper (A–B, PZ.02; A–C, PZ.02) or reading bills (A–B, PZ.04; A–C, PZ.004). Group C also had significantly less difficulty driving at night than Group B (P<.01). Near visual acuity and contrast sensitivity were significantly correlated with difficulty in near visual tasks in Groups B and C. Night-driving difficulty correlated significantly with contrast sensitivity in Group B. CONCLUSIONS: Patients with multifocal IOLs could perform several daily tasks at near and intermediate distances, with less night-driving limitation with the full diffractive IOL than with apodized multifocal and monofocal IOLs. Financial Disclosure: No author has a financial or proprietary interest in any material or method mentioned. J Cataract Refract Surg 2011; 37:638–648 Q 2011 ASCRS and ESCRS
The visual impairment caused by cataract can lead to a significant reduction in patients’ quality of life. Driving, reading, or performing other daily-life activities that depend on visual performance can become extremely difficult for these patients.1 The goal of modern cataract surgery is to achieve fast visual rehabilitation without complications and with low postoperative residual refractive errors,2 which would have a significant positive impact on the patient’s quality of life. New intraocular lens (IOL) designs aimed at restoring not only visual function at distance but also at near have been developed and introduced into clinical practice. This would theoretically provide complete 638
Q 2011 ASCRS and ESCRS Published by Elsevier Inc.
visual restoration, allowing the patient to successfully perform normal activities of daily living. Multifocal IOLs3 generate different foci in an attempt to solve the visual limitation at near and intermediate distances that occurs with classic monofocal IOLs. Indeed, multifocal IOLs have been shown to provide near and distance functional vision without the need for corrective lenses.4–10 Optical side effects, such as decreased contrast sensitivity, glare disability, and halos, have been reported with some multifocal IOL models.11–16 These effects can significantly affect the patient’s visual performance and thus the patient’s satisfaction and quality 0886-3350/$ - see front matter doi:10.1016/j.jcrs.2010.10.056
QUALITY OF LIFE AFTER MULTIFOCAL IOL IMPLANTATION
of life. Some patients with significant visual improvement after surgery are very dissatisfied with the outcomes because their expectations were not met or their postoperative visual quality is limited. For this reason, the visual acuity measure is not sufficient to confirm a successful outcome after cataract surgery.17–20 Vision-specific, health-related quality-oflife instruments can be used as complementary tools for evaluating the general outcomes of a specific modality of cataract surgery. They have been shown to be valid instruments to evaluate the functional impairment related to vision.21 The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) measures the selfreported, vision-targeted health status of people with chronic eye disease.22–24 This questionnaire measures the effect of visual disability and visual symptoms on general health, such as emotional well-being and social functioning. It also measures the extent to which the eye disease affects a patient’s ability to live without pain, work productively, and interact with loved ones.25 The NEI VFQ-25 has been used with people who are free of eye disease as well as with those who have a specific ocular pathology, such as agerelated macular degeneration, cataract, glaucoma, and Graves ophthalmopathy.23,25,26 It has also been used to evaluate subjective visual function changes after various intraocular procedures, such as cataract or macular hole surgery.27 Therefore, the NEI VFQ-25 is useful for measuring health-related quality of life in patients with various eye diseases and treatments. The aim of the current study was to compare the vision-related quality of life using the NEI VFQ 25 questionnaire in patients with 1 of 3 types of IOLsd 2 multifocal models and 1 monofocal modeldand to correlate it with postoperative visual outcomes.
Submitted: April 28, 2010. Final revision submitted: October 21, 2010. Accepted: October 22, 2010. From Vissum Corporation–Instituto Oftalmologico de Alicante (Ali o, Plaza-Puche, Pi~ nero, Amparo, Rodrıguez-Prats, Ayala), the Division of Ophthalmology (Alio), Universidad Miguel Hernandez, and the Departamento de Optica, Farmacologıa y Anatomıa ~ (Pinero), Universidad de Alicante, Alicante, Spain. Supported in part by a grant from the Spanish Ministry of Health, Instituto Carlos III, Red Tematica de Investigacion Cooperativa en Salud “Patologıa ocular del envejecimiento, calidad visual y calidad de vida,” Subproyecto de Calidad Visual (RD07/0062). Corresponding author: Jorge L. Alio, MD, PhD, Vissum Corporation–Instituto Oftalmol ogico de Alicante, Avenida de Denia s/n, Edificio Vissum, 03016 Alicante, Spain. E-mail: [email protected].
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PATIENTS AND METHODS Patients This prospective case series comprised eyes of bilateral cataract patients. All patients were adequately informed and signed a consent form. The study adhered to the tenets of the Declaration of Helsinki and was approved by the local ethical committee. The inclusion criteria were cataract (Lens Opacity Classification System III28: NO1, C1, P1, or more severity) causing a significant reduction in visual quality, older than 45 years, and a minimum education level (reading ability). The exclusion criteria were active ocular disease and astigmatism higher than 3.00 diopters. Cataract patients who came to Vissum Instituto Oftalmol ogico de Alicante for consultation were randomized to receive bilateral implantation of 1 of the 3 IOL models using random-number sequence software. All patients received the same IOL model in both eyes (ie, no mix and match).
Surgical Technique All surgeries were performed by 1 of 3 experienced surgeons (J.L.A, J.L.R-P., J.J.) using the same standard technique of sutureless microincision phacoemulsification and the same protocol. All patients received topical anesthesia before surgery. Adequate dilation was obtained with intracameral mydriasis. The incision was placed on the axis of the positive corneal meridian. After the microincision was created, the incision was enlarged to approximately 3.0 mm for IOL implantation. Postoperative topical therapy included a combination of topical antibiotic and steroidal agents.
Intraocular Lenses The monofocal IOL in this study was the Acri.Smart 48S (Carl Zeiss Meditec AG). This single-piece spherical foldable acrylic IOL has a 25% water content in its fully hydrated state and hydrophobic surfaces.29 It has a biconvex–equiconvex 5.5 mm optic with a total diameter of 11.0 mm. Patients with this IOL were assigned to Group A. One of the multifocal IOLs in this study was the AcrySof ReSTOR SN6AD3 (Alcon Laboratories, Inc.), which is designed to provide quality near to distance vision by combining apodized diffractive and refractive technologies.8,9,13,30–32 The center of the IOL surface consists of an apodized diffractive optic (3.6 mm diameter) that focuses light for near through distance. The refractive region of the IOL bends light as it passes through the IOL to a focal point on the retina. This outer ring of the IOL surrounds the apodized diffractive region and is dedicated to focusing light for distance vision.8,9,13,30–32 Patients with this IOL were assigned to Group B. The other multifocal IOL in this study was the Acri.LISA 366D (Carl Zeiss Meditec AG), which is an aspheric bifocal biconvex refractive–diffractive design.5 This single-piece IOL has an optic diameter of 6.0 mm and an overall diameter of 11.0 mm. The surface is divided into main zones and phase zones; the phase zones assume the function of the steps of diffractive IOLs and have a mean refractive power corresponding to the zero diffractive power of the main zones. The incident light is distributed with 65% to distance focus and 35% to near focus.5 Patients with this IOL were assigned to Group C.
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Preoperative Examination Preoperatively, all patients had a full ophthalmologic examination including evaluation of the subjective refractive status, distance and near visual acuities, anterior segment evaluation at the slitlamp, tonometry (Goldmann tonometer), and indirect fundoscopy. Distance visual acuity was measured with Snellen charts and near visual acuity, with Radner Reading Charts.33 The Salzburg Reading Desk34 was used to measure binocular near visual acuity. The Salzburg Reading Desk consists of a sophisticated reading desk with 2 high-frequency repro lights, a constant illuminance level of 500 lux, 2 video cameras measuring the reading distance by stereo photometry, and a reading board with a variable angle (0 to 40 degrees). This desk allows measurement of reading time, distance, acuity, and speed using Radner Reading Charts as well as the angulation of the reading board. Other examinations were corneal topography (Costruzione Strumenti Oftalmici), biometry (IOLMaster, Carl Zeiss Meditec AG), and contrast sensitivity (CST 1800, Vision Science Research Corp.) under photopic conditions (85 candelas [cd]/m2) and low mesopic conditions (3 cd/m2). Quality of life was evaluated using of the NEI VFQ-25 questionnaire with the appendix NEI VFQ-39. The NEI VFQ-2524,35 consists of 25 items and a supplement of 14 additional items, all of which were taken from the original 52-item NEI VFQ. Among the 39 items of the NEI VFQ-25 plus supplement, 6 ask patients to grade their general health and vision, 20 rate difficulties with activities, and 13 ask about the level of agreement with statements describing the severity of problems associated with vision loss. The questions on difficulty with activities were rated on a scale of 1 to 6, with response choices including no difficulty, a little difficulty, moderate difficulty, extreme difficulty, stopped doing this because of your eyesight, and stopped doing this for other reasons/not interested. A rating response of 6 was scored as missing data. The questions on the level of agreement with statements describing role limitations due to vision loss were rated on a 5-point scale, ranging from agree all of the time to agree none of the time for 5 of the items and ranging from definitely true to definitely false for the remaining 8 items. Two items in the supplement rated overall health and vision on a 0 (worst) to 10 (best) scale. In addition, patients were asked about their ability to perform tasks under usual conditions with correction (if needed) or without correction. Patients were not asked about their ability to perform task without correction only.
Postoperative Examination Patients were evaluated postoperatively at 1 day and 1 and 3 months. The postoperative examination protocol at 1 month and 3 months was identical to the preoperative protocol.
Statistical Analysis Statistical analysis was performed using SPSS for Windows software (version 15.0.1, SPSS, Inc.). The mean values and standard deviations were calculated for every parameter. Normality of all data samples was first checked using the Kolmogorov-Smirnov test. When parametric analysis was possible, 1-way analysis of variance with Bonferroni post hoc comparison was used to compare results between the 3 IOL groups. If variances were not homogeneous
(checked by the Levene test), Tamhane post hoc analysis was used. In all cases, a P value less than 0.05 was considered statistically significant. When parametric analysis was not possible, the Kruskal-Wallis test was used to compare the IOL groups using the same level of significance (P!.05). For post hoc analysis, the Mann-Whitney test with the Bonferroni adjustment was used to avoid the experimental error rate. In addition, correlation coefficients (Pearson or Spearman depending on whether normality condition could be assumed) were used to assess the correlation between variables.
RESULTS The study enrolled 106 eyes of 53 patients. Group A comprised 26 eyes; Group B, 38 eyes; and Group C, 42 eyes. Table 1 shows the preoperative data by IOL group. There were no statistically significant differences in age (PZ.11), axial length (PZ.16), or manifest cylinder (PZ.15) between the 3 groups. There were also no significant differences preoperatively between groups in any item on the quality-of-life questionnaire (PR.08). There were statistically significant differences in sphere between the groups (PZ.02), with a trend toward more preoperative myopia in Group C. Although there were no statistically significant differences in binocular logRAD uncorrected near visual acuity (UNVA) between groups (PZ.56), statistically significant differences were found in binocular logRAD corrected near visual acuity (CNVA) (PZ.03). Visual Acuity and Refraction Table 2 shows a comparative analysis of the visual and refractive outcomes and other clinical findings 3 months postoperatively. There were no statistically significant differences in manifest sphere or cylinder between the 3 IOL groups (PR.050). There were also no statistically significant differences in distance visual acuities (PR.11). The binocular logRAD was significantly better in eyes with multifocal IOLs (all P %.01). The difference between groups in binocular logRAD CNVA was at the limit of statistical significance (PZ.05), with the best mean outcome in Group C. Contrast Sensitivity Preoperatively, there was no statistically significant difference in contrast sensitivity outcomes at any spatial frequency between groups (PR.19). However, postoperative photopic contrast sensitivity was significantly better at spatial frequencies of 3, 6, and 18 cycles per degree (cpd) in the monofocal IOL group (3 cpd: Group A versus Group B, PZ.01; Group A versus Group C, PZ.03; Group B versus Group C, PZ.73) (6 cpd: PZ.01, PZ.01, and PZ.27, respectively) (18 cpd: P!.01, P!.01, and PZ.06, respectively). The contrast sensitivity at 12 cpd under photopic conditions
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Table 1. Comparison of the preoperative patient data by group.
Parameter Age (y) Mean G SD Range Median UDVA (logMAR) Monocular Mean G SD Range Median Binocular Mean G SD Range Median Sphere (D) Mean G SD Range Median Cylinder (D) Mean G SD Range Median CDVA (logMAR) Monocular Mean G SD Range Median Binocular Mean G SD Range Median UNVA (logRAD) Mean G SD Range Median CNVA (logRAD) Mean G SD Range Median IOP (mm Hg) Mean G SD Range Median AL (mm) Mean G SD Range Median
Group A (Monofocal IOL)
Group B (Apodized IOL)
Group C (Full Diffractive IOL)
65.62 G 8.93 51, 78 69.00
63.16 G 8.93 49, 80 64.00
59.09 G 8.79 50, 77 56.00
1.12 G 0.69 0.00, 2.00 0.13 0.92 G 0.60 0.30, 2.00 0.70 0.13 G 4.71 10.75, C7.75 0.00 1.07 G 0.86 3.00, 0.00 1.00
0.63 G 0.40 0.10, 1.52 0.20 0.48 G 0.38 0.00, 1.30 0.49
P Value Post Hoc Comparison P Value
A–B
A–C
B–C
.11*
.99
.13
.46
!.01†
!.01
!.01
.80
.02†
.01
.01
.71
!.01†
.07
!.01
.02
.15†
.11
.07
.80
!.01†
.02
!.01
.02
!.01†
!.01
!.01
.67
.57†
.32
.39
.86
.03†
!.01
!.01
.68
.20†
.40
.42
.08
.16z
.38
.21
.99
0.60 G 0.38 0.00, 1.78 0.22 0.48 G 0.31 0.00, 1.00 0.52
C1.19 G 2.31 4.50, C5.50 C2.50
C2.57 G 2.46 5.50, C8.00 C1.75
0.78 G 0.65 2.50, 0.00 0.75
0.73 G 0.62 2.50, 0.00 0.62
0.22 G 0.24 0.08, 1.00 0.22
0.10 G 0.13 0.00, 0.44 0.05
0.04 G 0.09 0.00, 0.40 0.00
0.20 G 0.04 0.08, 0.40 0.30
0.03 G 0.07 0.00, 0.22 0.00
0.02 G 0.05 0.0, 0.22 0.00
0.60 G 0.28 0.26, 1.05 0.53
0.65 G 0.22 0.13, 0.95 0.70
0.66 G 0.20 0.30, 0.91 0.73
0.28 G 0.19 0.07, 0.65 0.24
0.15 G 0.17 0.07, 0.66 0.12
0.13 G 0.11 0.04, 0.34 0.12
15.54 G 2.03 12, 19 15.00
16.21 G 2.79 11, 22 16.00
15.00 G 2.72 9, 21 15.50
23.47 G 1.58 20.77, 27.21 23.46
22.99 G 1.16 20.85, 25.69 23.08
22.90 G 1.14 20.62, 25.09 22.81
AL Z axial length; CDVA Z corrected distance visual acuity; CNVA Z binocular corrected near visual acuity; IOL Z intraocular lens; IOP Z intraocular pressure; UDVA Z uncorrected distance visual acuity; UNVA Z binocular uncorrected near visual acuity *Analysis of variance † Kruskal-Wallis z One-way analysis of variance
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Table 2. Comparison of the 3-month postoperative data by group. P Value Post Hoc Comparison Parameter UDVA (logMAR) Monocular Mean G SD Range Median Binocular Mean G SD Range Median Sphere (D) Mean G SD Range Median Cylinder (D) Mean G SD Range Median CDVA (logMAR) Monocular Mean G SD Range Median Binocular Mean G SD Range Median UNVA (logRAD) Mean G SD Range Median CNVA (logRAD) Mean G SD Range Median
Group A
Group B
Group C
0.09 G 0.14 0.00, 0.52 0.03
0.13 G 0.13 0.00, 0.40 0.10
0.10 G 0.11 0.00, 0.52 0.08
0.03 G 0.06 0.00, 0.15 0.00
0.05 G 0.08 0.00, 0.30 0.00
0.05 G 0.10 0.00, 0.40 0.00
0.08 G 0.45 1.00, C0.50 0.00
C0.36 G 0.48 0.50, C1.50 C0.50
C0.15 G 0.55 1.25, C1.50 0.00
0.63 G 0.44 2.00, 0.00 0.50
0.63 G 0.44 2.00, 0.00 0.75
0.53 G 0.38 1.25, 0.00 0.50
0.02 G 0.05 0.00, 0.15 0.00
0.02 G 0.03 0.00, 0.10 0.00
0.01 G 0.03 0.04, 0.12 0.00
0.02 G 0.04 0.00, 0.13 0.00
G0.02 0.00, 0.08 0.00
0.00 G 0.03 0.04, 0.10 0.00
0.47 G 0.22 0.15, 0.87 0.48
0.28 G 0.04 0.11, 0.77 0.18
0.19 G 0.08 0.07, 0.37 0.17
0.24 G 0.19 0.02, 0.69 0.21
0.21 G 0.14 0.01, 0.46 0.17
0.15 G 0.01 0.02, 0.27 0.15
P Value
A–B
A–C
B–C
!.01†
!.01
!.01
.80
.49*
.01
.37
.67
.09
.26
.15
.66*
.48
.88
.39
.11*
.39
.32
.12
.24*
.12
.16
.93
!.01*
!.01
!.01
.20
.21*/.051†
!.01
.99
.29
.050*/.01
CDVA Z corrected distance visual acuity; CNVA Z binocular corrected near visual acuity; UDVA Z uncorrected distance visual acuity; UNVA Z binocular uncorrected near visual acuity *Kruskal-Wallis † One-way analysis of variance
was significantly better in Group A (Group A versus Group B, PZ.02; Group A versus Group C, PZ.20; Group B versus Group C, PZ.04). Contrast sensitivity under mesopic conditions was significantly better at 6 cpd and 18 cpd in Group A (6 cpd: Group A versus Group B, PZ.02; Group A versus Group C, PZ.08) (18 cpd: PZ.01 and PZ.02, respectively) (Figure 1). Quality-of-Life Outcomes Postoperatively, Groups B and C had significantly less difficulty than Group A in reading the newspaper
and bills (P%.04) (Figure 2, A and B). Groups B and C had significantly less difficulty than Group A performing hobbies that required near vision (P%.01) (Figure 2, C). There were no statistically significant differences between Group B and Group C in these 3 areas (PR.28). In addition, Group C had significantly less difficulty driving at night than Group B (PZ.01); however, there were no significant differences in this parameter between Group A and Group B (PZ.14) or between Group A and Group C (PZ.74) (Figure 2, D). The scores for difficulty under night-driving conditions were lower in Group A than in Group C,
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Figure 1. Mean contrast sensitivity function by IOL group under photopic and mesopic low conditions (cd Z candelas; cpd Z cycles per degreee; CS Z contrast sensitivity; CSF Z contrast sensitivity function).
although the difference did not reach statistical significance. The difference in sample sizes could have accounted for this lack of significance, despite the trend. There were no statistically significant correlations between quality-of-life items and the clinical data in Group A. Tables 3 and 4 show the statistically significant correlations between different quality-of-life items and clinical parameters in Group B and Group C, respectively. Significant correlations were found between some visual acuity and contrast sensitivity parameters and the subjective perception of quality of vision and difficulty reading. In addition, there were several significant correlations between contrast sensitivity and different types of driving conditions in Group C. Complications No complications occurred intraoperatively or postoperatively. No case of capsule opacification was detected during the 3-month follow-up. DISCUSSION Intraocular lenses represent one of the major landmarks of the correction of aphakia after cataract surgery. Since Ridley invented IOLs in the 1950s,36 several improvements in their design and materials
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have been introduced, including the development of models to correct presbyopia. In the past several years, multifocal IOLs have been introduced into clinical practice with the aim of improving near vision and reducing dependence on reading glasses.4 However, visual quality problems have been described with some multifocal models,6,14,37–39 and these can limit their potential benefit. Specifically, diffractive IOLs have been associated with photic phenomena such as glare or halos.14,37 These optical side effects can negatively affect daily-life activities, limiting the patient’s ability to perform them and thus affecting the patient’s quality of life.40 The aim of the current study was to evaluate the quality of life with a validated questionnaire in patients with bilateral implantation of a standard monofocal IOL (Acri.Smart 48S), an apodized multifocal IOL (AcrySof ReSTOR SN6AD3), or a full diffractive IOL (Acri.LISA 366D). Both multifocal IOL models have an aspheric design to reduce the unwanted visual phenomena normally associated with other multifocal IOL designs and to increase the range of focus, improving retinal image quality.41 Previous studies42–45 show that aspheric optics provide better contrast sensitivity than spherical optics. As expected, there was significant improvement in distance vision postoperatively in all 3 IOL groups. This is consistent with findings in other studies.5,8,18,31,37,46 The uncorrected and corrected distance visual acuities were similar in the 3 groups. There was a significant improvement in UNVA and distancecorrected near visual acuity in all groups, as reported in previous studies.7,8,18,29,31,37,47 However, the 2 multifocal IOLs provided better near vision than the monofocal IOL, confirming the efficacy of these 2 models in restoring near visual function. This was expected because previous studies16,48–51 report better near visual performance with multifocal IOLs than with monofocal IOLs. Regarding postoperative contrast sensitivity, higher mean contrast sensitivity values were observed in eyes with the monofocal IOL, with statistically significant differences between all 3 groups in contrast sensitivity values under photopic conditions at all spatial frequencies analyzed. This is consistent with results in previous studies8,48,51 in which monofocal IOLs provided better contrast sensitivity outcomes than multifocal IOLs. There is a compromise between optical quality and near visual performance with multifocal IOLs; that is, the better the near vision, the more significant the aberrometric or scattering components. We evaluated the patients’ quality of life using the Spanish version of a validated questionnaire, the NEI VFQ-25.52 This questionnaire was initially developed to evaluate the visual impact of ocular pathology
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Figure 2. Differences in quality-of-life items between the 3 IOL groups. The boxes represent the 25% to 75% range; the thick black lines, the median; the whiskers, the highest and lowest values that were not outliers or extreme values; the circle, an outlier (value between 1.5 and 3.0 times the interquartile range); and the asterisks, extreme values (values more than 3 times the interquartile range).
on daily tasks and the quality of life.23–26 Several studies24,53–55 show the questionnaire to be reliable and valid for people with different visual acuity levels and conditions. To our knowledge, this is the first study to evaluate and compare the quality of life in patients with the 3 IOL models we used. As expected, patients with the multifocal IOLs had less difficulty performing near tasks, such as reading. In addition, these patients achieved significantly better postoperative near visual outcomes. This is consistent with findings in previous studies that showed an improvement in near tasks with other multifocal IOL models.9,40,56–58 Patients with the Acri.LISA 366D IOL reported less difficulty driving at night than patients with the hybrid AcrySof ReSTOR SN6AD3 IOL. Photic phenomena have been reported to be more frequent in eyes with multifocal IOLs, and these phenomena could negatively affect night driving.39
Choi and Schwiegerling59 performed simulations in a model eye with different IOL designs and found fewer stray-light artifacts under scotopic conditions in eyes with AcrySof ReSTOR multifocal IOLs than in eyes with full refractive or diffractive IOLs. The authors state that aspheric multifocal IOLs would provide some visual benefit by minimizing ocular aberrations, which may be the reason for our findings. Both multifocal IOL models in our study have an aspheric profile with the aim of providing better contrast sensitivity function as a result of less induction of aberrations; however, the aspheric profile of the 2 IOL models seems to be different (ie, different Q factor). Complete knowledge of all details of the design of these 2 IOL models is necessary to determine the exact reason for our findings. We did not measure the pupil size in this study. By doing so, it would have allowed us to provide a more
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Table 3. Correlations between quality-of-life items and visual parameters 3 months postoperatively in Group B. Quality-of-Life Item General health (1 Z excellent, 5 Z bad) General vision (1 Z Worst, 10 Z best) Difficulty reading (1 Z no difficulty, 5 Z extreme difficulty)
Correlation 1
Correlation 2
Correlation 3
Cylinder r Z 0.781; P!.01 Binocular at UDVA r Z 0.693, PZ0.04 Photopic CSF at 12 cpd r Z 0.913, PZ.03
d
d
Photopic CSF at 18 cpd r Z .892, PZ.04 Binocular UNVA r Z 0.822, PZ.007
d Binocular CNVA r Z 0.822, PZ.007
CNVA Z corrected near visual acuity (logRAD); cpd Z cycles per degree; CSF Z contrast sensitivity function; UDVA Z uncorrected distance visual acuity; UNVA Z uncorrected near visual acuity (logRAD)
complete report of the outcomes. This can be considered a limitation of the study but not a source of bias in the interpretation of outcomes. The 3 IOL groups had a similar age (age and pupil size are related60), and theoretically, none of the 3 IOLs is dependent on pupil size. Our research group found some years ago that pupil size had little effect on intraocular aberrations in eyes with AcrySof ReSTOR IOLs.61 Another potential limitation of our study is the inclusion of data from different surgeons. However, all surgeons used the same surgical protocol, which should have minimized the role of the surgeon factor in the variability in outcomes. Finally, correlations between quality of life and clinical data were evaluated. As expected, we found statistically significant correlations with difficulties in some near and intermediate visual tasks (eg, between reading the newspaper and near visual acuity) in the 2 multifocal IOL groups. These difficulties were also
significantly correlated with contrast sensitivity in the 2 groups. Based on these findings, the optical degradation in eyes with a multifocal IOL seemed to induce deterioration not only in distance vision but also in near vision, a finding that has been reported with other multifocal IOLs.14 Furthermore, there was an inverse significant correlation between difficulty driving at night and contrast sensitivity in eyes with the hybrid IOL, suggesting that this design is more likely to induce night-driving problems when contrast sensitivity is affected (eg, high IOL power, slight IOL decentration). These trends should be confirmed and validated in future studies. Quality of life is a multifactorial process and is not dependent on visual performance only. Some studies of different IOLs22,62 found no significant change in quality of life indices (using normalized questionnaires) despite improvement in certain clinical parameters. Thus, we avoided the use of general quality-of-life
Table 4. Correlations between quality-of-life items and visual parameters 3 months postoperatively in Group C. Quality-of-Life Item General vision (1 Z Worst, 10 Z best) Difficulty reading (1 Z no difficulty, 5 Z extreme difficulty) Difficulty reading bills (1 Z no difficulty, 5 Z extreme difficulty) Difficulty in general vision (1 Z no difficulty, 5 Z extreme difficulty) Difficulty going to cinema (1 Z no difficulty, 5 Z extreme difficulty) Difficulty driving (1 Z no difficulty, 5 Z extreme difficulty) Difficulty driving at night (1 Z no difficulty, 5 Z extreme difficulty) Difficulty driving in difficult conditions (1 Z no difficulty, 5 Z extreme difficulty)
Correlation 1
Correlation 2
Correlation 3
Binocular UDVA r Z 0.571, PZ.01 Sphere r Z 0.496, PZ.03 Sphere r Z 0.496, PZ.03 Binocular CDVA r Z 0.513, PZ.04 Binocular CDVA r Z 0.540, PZ.02 Scotopic CSF at 6 cpd r Z 0.615, PZ.01 Scotopic CSF at 6 cpd r Z 0.632, PZ.009 Scotopic CSF at 6 cpd r Z 0.646, PZ.007
Binocular CDVA r Z 0.585, PZ.01 Binocular CDVA r Z 0.554, PZ.02 d
d Binocular CNVA r Z 0.591, PZ.02 d
d
d
d
d
d
d
d
d
d
d
CDVA Z corrected distance visual acuity; CNVA Z corrected near visual acuity (logRAD); cpd Z cycles per degree; CSF Z contrast sensitivity function; UDVA Z uncorrected distance visual acuity
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indices (eg, Do you feel depressed? Are you happy?) and centered our analysis on those with a theoretical relationship to vision. One drawback of our study is the limitation of the randomization process. The number of eyes in the 3 groups differed; thus, we cannot make generalized conclusions that would be valid for the entire population. Larger numbers of cases would have been required for to make such conclusions. Furthermore, the asymmetric distribution could have been the cause of the borderline results we observed, such as the P value of 0.051 for the difference between groups in binocular logRAD CNVA. Therefore, more research is required to ascertain and specify with accuracy the complete impact on the quality of life of new IOL models for cataract surgery. Other types of IOLs should be included in this type of analysis. In summary, results indicate that AcrySof ReSTOR SN6AD3 and the Acri.LISA 366 D multifocal IOLs can restore near visual function after cataract surgery, allowing the patient to perform several daily tasks at near and intermediate distances and thus providing spectacle independence. The aspheric diffractive IOL (Acri.LISA 366D) provided the least limitation in night-driving performance. However, difficulty in night driving was significantly dependent on contrast sensitivity with the aspheric hybrid model (AcrySof ReSTOR SN6AD3). Furthermore, the monofocal IOLs provided distance visual restoration with a limited impact on near vision; it provided acceptable night-driving performance. Future research focused on establishing the exact relationship between quality of life and ocular optical quality is required to understand the problems reported by patients with different IOL models. REFERENCES
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First author: Jorge L. Ali o, MD, PhD Vissum Corporation-Instituto Oftalmologico Alicante, Alicante, Spain