Functional vision after cataract removal with multifocal and accommodating intraocular lens implantation Prospective comparative evaluation of Array multifocal and 1CU accommodating lenses Charles Claoue´, MD, DO, FRCS, FRCOphth, FEBO Purpose: To compare the efficacy (functional vision, spectacle dependence) of the Array威 multifocal intraocular lens (IOL) (Advanced Medical Optics) and the 1CU accommodating IOL (HumanOptics AG). Setting: Hartswood Hospital, Brentwood, United Kingdom. Methods: This prospective study comprised patients scheduled to have standard phacoemulsification surgery with IOL implantation. Patients expressing a preference for spectacle independence were allocated to the Array multifocal IOL group. Those expressing no preference received the 1CU accommodating IOL. Efficacy measures included distance and near uncorrected visual acuity (UCVA), dynamic retinoscopy, and patient-reported spectacle independence. Results: Seventeen patients (34 eyes) had bilateral implantation of the Array multifocal IOL, and 5 patients (9 eyes) had implantation of the 1CU accommodating IOL. Six to 18 months after surgery, 82.4% of eyes in the multifocal IOL group and 77.8% in the accommodating IOL group achieved a distance UCVA of 20/20 (Snellen) or better; the difference between groups was not significant. However, a significantly greater proportion in the multifocal IOL group than in the accommodating IOL group (76.5% versus 44.4%) achieved a near UCVA of N5 (Snellen 20/40) or better (P ⫽ .0068). Sixteen patients (94.1%) with Array IOLs and 2 patients (50.0%) with 1CU IOLs reported spectacle independence. Dynamic retinoscopy showed that the mean accommodative effect in the 1CU group was 0.44 diopter. Conclusions: In this single-surgeon single-site study, a greater proportion of Array multifocal IOL recipients than 1CU IOL recipients achieved functional near visual acuity. Only 1 patient with an Array IOL required corrective spectacles at the last visit. J Cataract Refract Surg 2004; 30:2088–2091 2004 ASCRS and ESCRS
T
he ultimate goal of cataract surgery is to replace the cataractous crystalline lens with an intraocular lens (IOL) that provides the patient with a full range of functional vision—distance through near. Monofocal IOLs provide excellent distance vision, but patients are
Accepted for publication February 6, 2004. Reprint requests to Charles Claoue´, MD, DBCG, PO Box 12650, London SE3 9ZZ, United Kingdom. E-mail:
[email protected]. 2004 ASCRS and ESCRS Published by Elsevier Inc.
still dependent on spectacles for near and intermediate vision. Currently, this problem can be addressed by implanting a multifocal IOL such as the Array威 (Advanced Medical Optics). The Array is a distance-dominant, simultaneousvision, zonal-progressive IOL. Since its approval by the U.S. Food and Drug Administration in 1997, many studies have shown it to be safe and effective in correcting a range of vision, from far through near, after cataract removal; they also report its advantages over traditional 0886-3350/04/$–see front matter doi:10.1016/j.jcrs.2004.05.007
COMPARISON OF MULTIFOCAL AND ACCOMMODATING IOLS
monofocal IOLs.1–7 These studies show that eyes with an Array multifocal IOL achieve significantly better near uncorrected visual acuity (UCVA) than eyes with a monofocal IOL. Moreover, a greater proportion of patients with multifocal IOLs than patients with monofocal IOLs report being able to function comfortably without spectacles for near tasks. Some report never using spectacles.2–5,7 Although the Array multifocal IOL provides patients with functional vision at near through distance, the ultimate goal is to provide patients with an IOL that produces true accommodation and provides a range of vision equal or superior to that of the Array multifocal IOL. The 1CU (HumanOptics AG) is a foldable, posterior chamber, acrylic IOL with haptics designed to allow transduction of ciliary muscle contraction into anterior motion of the lens.8 The estimated theoretical accommodative response caused by the forward shift of the lens is between 1.21 diopters (D) and 1.81 D per millimeter, depending on the individual’s biometry.9,10 Subjective measures of accommodation (and pseudoaccommodation) show patients with a 1CU IOL have significantly better distance corrected near visual acuity and subjective near point vision than control patients with a control (monofocal) IOL. The 1CU IOL also performs significantly better than monofocal IOLs on objective measures of accommodation such as an improved retinoscopic accommodative range and a smaller anterior chamber after ciliary muscle stimulation with pilocarpine.8,11 Although both the Array multifocal IOL and the 1CU accommodating IOL compare favorably with monofocal lenses, no published study has directly compared the 2 lenses. This small single-site study compared the efficacy of Array and 1CU IOLs after implantation by the same experienced cataract surgeon. Care was taken to separate measurements of real accommodation achieved by the anterior shift of the IOL and pseudoaccommodation measured subjectively in reading tests. Thus, in addition to visual acuity tests, dynamic retinoscopy was performed to assess changes in the refractive power of the eye.
Patients and Methods Participants and Lens Allocation From September 2001 to September 2002, 33 patients scheduled to have routine phacoemulsification with implan-
tation of a posterior chamber IOL and with no other known pathology were prospectively recruited. All patients had a comprehensive ophthalmic examination. Only patients for whom bilateral surgery was anticipated were recruited into the study. Exclusion criteria included ocular pathology other than cataract, incomplete follow-up, and a target outcome that was not emmetropia. All patients were counseled as to the realistic expectations for both types of lenses. Patients who specified spectacle independence as their goal were allocated to receive the Array multifocal IOL; otherwise, they were allocated to receive the 1CU accommodating IOL.
Surgical Technique All surgery was performed at a single site by the author. Cataracts were extracted using standard phacoemulsification. The Array IOL was implanted using a forceps and the 1CU IOL, using an injector. After implantation of the 1CU lens, the haptics were unfolded in the capsular bag and rotated to a horizontal position according to previously described methods.8
Assessment of Study Outcomes Efficacy measures included subjective, objective, and functional assessment of the performance of the 2 IOLs. Uncorrected (UCVA) and best corrected (BCVA) visual acuities were assessed at distance and near in each eye. As subjective visual acuity measures can be affected by several factors including residual myopia, astigmatism, and small pupils, dynamic retinoscopy was performed to gain an objective measure of accommodation. Briefly, dynamic retinoscopy is performed using standard retinoscopy for distance to quantify the distance end point. The patient is then instructed to concentrate on a clearly visible target on the examiner’s retinoscope, and the new end point under these conditions is measured. The difference between the 2 values is the accommodation in diopters. To determine the patients’ satisfaction with their vision and their functional dependence on spectacles, they were asked whether they used spectacles. Patients were considered spectacle independent if they said “no”; patients giving any other answer were considered spectacle dependent. Statistical analysis was by the Wilcoxon 2-sample test.
Results Of the 33 patients initially recruited, 28 were allocated the Array multifocal IOL group and 5 were allocated the 1CU accommodating IOL group. Although the goal was to recruit the same number of patients in both groups and enrollment was extended from 6 to 12 months, fewer 1 CU patients could be recruited, in part because of cost. Of the 28 Array multifocal IOL
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Table 1. Patients’ demographics. IOL Group Characteristic
Array
1CU
Patients, n
17
5
Male
7
2
10
3
34
9
Mean
63.5
66.8
Range
46–83
51–79
Female Eyes, n Age, y
IOL ⫽ intraocular lens; n ⫽ number
patients, 11 were excluded from further analysis because of complicating pathology (age-related macular degeneration; 1 eye of 1 patient), lack of follow-up (1 eye of 1 patient; 4 patients with bilateral implantation), surgical complications (decentration leading to IOL exchange; 1 eye of 1 patient), and noncompletion of the second surgery (4 patients). After these exclusions, 43 eyes (22 patients) remained assessable, 34 eyes (17 patients with bilateral implantation) with Array multifocal IOLs and 9 eyes with 1CU accommodating IOLs (Table 1). One patient received a 1CU IOL in 1 eye; the patient obtained no effect and requested a monofocal IOL in the second eye. The data for the 1CU eye of this patient were excluded from analysis of spectacle dependence but included for visual acuity and accommodation. The follow-up ranged from 6 to 18 months. All eyes in both groups achieved a distance UCVA of 20/40 or better (P ⫽ .27). A distance UCVA of 20/20 or better was achieved by 82.4% (28 of 34 eyes) in the Array multifocal IOL group and 77.8% (7 of 9 eyes) in the 1CU accommodating IOL group (P ⫽ 1.0). A significantly greater proportion of eyes in the multifocal IOL group than in the accommodating IOL group (76.5% versus 44.4%) achieved a near UCVA of N5 (Snellen
Figure 1. (Claoue´) Comparison of subjective and functional visual acuity between the Array multifocal IOL (black bars) and the 1CU accommodating IOL (gray bars).
20/40) or better (P ⫽ .0068) (Figure 1 and Table 2). All patients had a BCVA of 20/20 or better. The mean accommodation measured objectively with dynamic retinoscopy in the 1CU IOL group was 0.44 D. No accommodation was seen in 4 of the 9 eyes with a 1CU IOL; accommodation up to 1.00 D was seen in the other 5 eyes. All patients but 1 (94.1%) with Array multifocal IOLs and 2 patients (50.0%) with 1CU IOLs reported being spectacle independent.
Discussion This is the first published study comparing an accommodating IOL with the Array multifocal IOL. Although much was expected of the 1CU accommodating lens, its optical performance did not permit the degree of spectacle independence that the Array multifocal IOL did. Indeed, the accommodation provided by the 1CU was less than the multifocal vision provided by the Array multifocal IOL. Only 44% of eyes with the 1CU accommodating IOL achieved reasonable uncorrected
Table 2. Comparison of the Array multifocal IOL and 1CU accommodating IOL in subjective, functional, and objective measures of vision. Array IOL (n ⫽ 34)
1CU IOL* (n ⫽ 9)
Eyes with distance UCVA 20/20 or better, n (%)
28 (82.4)
7 (77.8)
Eyes with near UCVA N5 (20/40) or better, n (%)
26 (76.5)
2 (44.4)
.0068
Patients reporting spectacle independence, n (%)
16 (94.1)
2 (50.0)
—
—
0.44
—
Measurement
Objective accommodation by dynamic retinoscopy (D) UCVA ⫽ uncorrected visual acuity *The 1 patient with a unilateral 1CU IOL was excluded from this assessment.
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P Value 1.0
COMPARISON OF MULTIFOCAL AND ACCOMMODATING IOLS
near visual acuity (N5 or better, equivalent to Snellen 20/40). In contrast, 76% of eyes with the Array multifocal IOL achieved this level of acuity. All but 1 patient with Array multifocal IOLs could function without spectacles. In contrast, only half the patients with bilateral 1CU IOLs could function without spectacles. Many cataract patients have been presbyopic and dependent on spectacles for years, so the ability to perform everyday tasks without reading glasses significantly improves their quality of life. Dynamic retinoscopy revealed an accommodation of no more than 1.00 D (mean 0.44 D) in eyes with a 1CU accommodating IOL. This does not approach the predicted accommodative power of the lens. The change in anterior chamber depth caused by the shift of the lens predicts an accommodation of 1.13 D or 1.40 D depending on the technique used.11 The value patients place on becoming less dependent on spectacles is reflected in the asymmetry of the groups: Nearly 85% of patients initially recruited stated a strong preference for spectacle independence. It is possible that the large cost difference between the 2 lenses led some patients suitable for the 1CU to decline it in favor of a less costly, standard monofocal IOL, thereby excluding them from the study. However, because several of the Array patients were subsequently excluded, 76% of patients completing the study had stated a preference for spectacle independence (and therefore received Array multifocal IOLs). Although this allocation method effectively matched patient preferences with the likely end result of surgery, it also brought differing motivation into the equation. Patients in the 1CU group, who expressed no strong preference for spectacle independence, may have held lower expectations for surgery than the motivated Array group. This expectation and motivation may influence spectaclewearing behavior after surgery. The small size of the cohort and the asymmetric groups are also not ideal. Further comparison of these lenses in a larger randomized masked study is advisable.
Conclusion
allowing almost all patients with an Array IOL to dispense with corrective spectacles.
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In this single-surgeon single-site study, the Array multifocal IOL outperformed the 1CU accommodating IOL. A greater proportion of Array IOL recipients than 1CU IOL recipients had functional near visual acuity,
Presented at the ASCRS Symposium on Cataract, IOL and Refractive Surgery, San Francisco, California, USA, April 2003. The author has no financial or proprietary interest in any material or method mentioned.
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