- Email: [email protected]
Influence of sclerotomy size on intraocular lens tilt after intrascleral intraocular lens fixation
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ARTICLE
Influence of sclerotomy size on intraocular lens tilt after intrascleral intraocular lens fixation Takehiro Matsumura, MD, PhD, Yoshihiro Takamura, MD, PhD, Jun Makita, MD, PhD, Akira Kobori, MD, Masaru Inatani, MD, PhD
Purpose: To determine whether differences in sclerotomy size
Results: The study included 65 eyes (60 patients). Postopera-
during intrascleral intraocular lens (IOL) fixation influence IOL tilt and visual acuity after surgery.
tively, the maximum degree of IOL tilt was significantly smaller in the 24-gauge sclerotomy group than in the 30-gauge sclerotomy group (P Z .003). The degree of IOL tilt was significantly correlated with the amount of postoperative IOL astigmatism (total astigmatism corneal astigmatism) (P Z .0001, R2 Z 0.23). There were no statistically significant differences in the preoperative or postoperative corrected distance visual acuity (CDVA) or the complication rate between the sclerotomy groups.
Setting: University of Fukui Hospital and Japanese Red Cross Fukui Hospital, Japan.
Design: Retrospective case series. Methods: The study reviewed the records of patients who had intrascleral IOL fixation with transconjunctival 25-gauge pars plana vitrectomy and a follow-up longer than 6 months. The preoperative and postoperative visual outcomes, degree of IOL tilt, and intraoperative and postoperative complications were statistically compared between the sclerotomy groups.
I
n eyes without sufficient posterior capsule support, an intraocular lens (IOL) can be implanted in the anterior chamber, fixated to the iris, or transsclerally fixated through the ciliary sulcus or pars plana.1–6 To date, a transscleral sutured posterior chamber IOL has primarily been used in the transscleral fixation technique.2–6 Recently, sutureless intrascleral IOL fixation has become popular; however, the long-term outcomes of this approach remain unclear.7–15 Compared with conventional transscleral suturing of an IOL, sutureless intrascleral IOL fixation has benefits, such as tight fixation of the IOL haptics inserted in the scleral tunnels, no suture breakage,16 and a lower incidence of IOL decentration,17 vitreous hemorrhage,18 and endophthalmitis resulting from suture exposure. Several improved techniques, such as the glued-IOL method,8 Y-fixation method,10 and double-needle
Conclusion: A smaller sclerotomy for intrascleral IOL fixation was associated with greater IOL tilt and IOL astigmatism after surgery; however, this did not clinically or significantly affect the postoperative CDVA. J Cataract Refract Surg 2019; 45:1446–1451 Q 2019 ASCRS and ESCRS
method,11 have been reported for fixation of IOL haptics. However, haptic fixation with the intrascleral technique differs from that with other IOL haptic fixation methods.7,8,10–12,19,20 In particular, the techniques of lamellar scleral dissection and for creating a scleral tunnel for embedding IOL haptics allow the surgeon to pull out and fix the haptics in a simple and safe manner.10,11 In intrascleral IOL fixation, sclerotomies are created using a 20-, 22-, 23-, 24-, 25-, 27-, or 30-gauge needle.7–11,14,19,21 Small sclerotomies are expected to reduce the incidence of postoperative complications, such as hypotony or ciliary body injury.11 However, it remains unknown whether the postoperative visual acuity and IOL stability are affected by the size of the sclerotomy. Therefore, we sought to determine whether sclerotomy size influences postoperative visual acuity and IOL tilt.
Submitted: April 23, 2019 | Final revision submitted: June 9, 2019 | Accepted: June 11, 2019 From the Departments of Ophthalmology, Faculty of Medical Sciences, University of Fukui (Matsumura, Takamura, Inatani), Tokyo Dental College Ichikawa General Hospital (Matsumura), Chiba, Saitama Medical University Hospital (Makita), and Japanese Red Cross Fukui Hospital (Kobori), Fukui, Japan. Supported in part by Grants-in-Aid for Scientific Research (#18K16951), Japan Society for the Promotion of Science, Tokyo. Corresponding author: Yoshihiro Takamura, MD, PhD, Department of Ophthalmology, Faculty of Medical Sciences, University of Fukui, 23-3 Shimoaizuki, Matsuoka, Eiheiji, Fukui, 910-1193, Japan. Email: [email protected]. Q 2019 ASCRS and ESCRS Published by Elsevier Inc.
0886-3350/$ - see frontmatter https://doi.org/10.1016/j.jcrs.2019.06.006
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IOL TILT AFTER INTRASCLERAL FIXATION
PATIENTS AND METHODS This retrospective interventional case series reviewed data from the University of Fukui Hospital and Japanese Red Cross Fukui Hospital. The study was approved by the University of Fukui Hospital Institutional Review Board (approval #20180037) and was performed in accordance with the tenets of the Declaration of Helsinki. The medical records of consecutive patients who had intrascleral IOL fixation with transconjunctival 25-gauge pars plana vitrectomy between April 1, 2012, and December 31, 2017 were retrospectively assessed. The study protocol was disclosed, and the patients were given the opportunity to refuse to participate in the study. The inclusion criteria were as follows: at least 20 years of age, treatment with intrascleral IOL fixation for aphakia, a subluxated crystalline lens or a dislocated IOL, and a postoperative follow-up longer than 6 months. The exclusion criteria were retinal disease requiring treatment (eg, retinal detachment or vitreous hemorrhage) and scleritis. Also excluded were patients who did not agree to follow the study protocol. The information collected retrospectively from the medical records included age, sex, preoperative lens status, axial length, corneal diameter, preoperative and postoperative refractive power, corrected distance visual acuity (CDVA), intraocular pressure (IOP), degree of IOL tilt, IOL power, sclerotomy size, and intraoperative and postoperative complications. Postoperative hypotony and IOP elevation were defined as an IOP less than 6 mm Hg and an IOP greater than 25 mm Hg, respectively. Surgical Technique Intrascleral IOL fixation was performed as previously described10,11 with some modifications. A 25-gauge pars plana vitrectomy was performed using the Constellation Vision System (Alcon Laboratories, Inc.) under retrobulbar anesthesia. Phacoemulsification was performed for subluxated crystalline lenses; a vitrectomy cutter was used if part of the crystalline lens fell into the vitreous cavity. If the dislocated IOL was made of a soft material, it was cut into 2 or 3 pieces and extruded through the 3.0 mm sclerocorneal incision. Dislocated poly(methyl methacrylate) IOLs were extruded through the 6.0 mm sclerocorneal incision. Two T-shaped lamellar scleral incisions were created 2.0 mm from the limbus exactly 180 degrees apart diagonally. Scleral tunnels were made parallel to the limbus at the branching point of the
T-shaped incision. The sclerotomy was made at the T-shaped incision with a 24-gauge angled microvitreoretinal knife, or an angled sclerotomy was made with a 27-gauge or 30-gauge needle. A 3-piece IOL (X-70 or NX-70, Santen Pharmaceutical Co., Ltd.) was implanted in the anterior chamber with an injector; the trailing haptic was kept outside to prevent the IOL from falling into the vitreous cavity. Both haptics were grasped with a forceps and pulled through the sclerotomy or externalized onto the sclera using the double-needle technique. The ends of the haptics were subsequently inserted into the limbus-parallel scleral tunnels with a forceps, after which the IOL was centered. A peripheral iridotomy was performed using the vitrectomy cutter after miosis to prevent reverse iris block and iris capture of the IOL. A single 9-0 nylon suture was used to fixate the haptic to the scleral bed. Wounds were not sutured if there was no leakage from the sclerotomy. The infusion cannula was removed after IOL fixation. Intraocular Lens Tilt Measurements Three months after surgery, the angle of IOL tilt was measured with swept-source optical coherence tomography (SS-1000 CASIA, Tomey Corp.) using a standardized radial scan performed after pupil dilation. The visual line passing through the cornea to the pupil was used as the reference line.22 The angle between the reference line and the horizontal axis of the IOL was taken as the IOL tilt. The radial scan acquired 512 A/B-scan images, each containing 128 B/C scans with a length of 16.0 mm. The IOL tilt was measured using the radial scan images. The maximum angle of IOL tilt was determined over all the radial scan images and was defined as the maximum degree of IOL tilt. For comparison, the degree of IOL tilt with intracapsular fixation was measured in 20 patients who had phacoemulsification and 25-gauge pars plana vitrectomy to treat cataract and epiretinal membrane. Statistical Analysis Statistical analyses were performed using JMP software (version 10, SAS Institute, Inc.). The CDVA was recorded in decimal units and then converted to logarithm of the minimum angle of resolution notation for statistical analysis. The Wilcoxon signed-rank test was used to compare the preoperative CDVA and postoperative CDVA. The Tukey-Kramer test was used to compare the mean maximum degree of IOL tilt, changes in refractive power,
Table 1. Patient demographic data. Characteristic Eyes (n) Age (y) Mean G SD Range Sex, n (%) Male Female Surgical eye Right Left Axial length (mm) Mean G SD Range Diagnosis (n) Subluxated crystalline lens Dislocated IOL Aphakia
Total
24-Gauge
27-Gauge
30-Gauge
P Value
65
21
14
30
d
70.9 G 14.7 21, 92
67.9 G 18.4 21, 89
66.3 G 14.6 38, 82
75.3 G 10.5 49, 92
.08 .87
43 (66) 22 (34)
14 (67) 7 (33)
10 (71) 4 (29)
19 (63) 11 (37)
29 36
10 11
5 9
14 16
24.36 G 2.34 20.95, 32.64
24.72 G 2.69 21.74, 32.64
24.05 G 1.99 21.74, 28.28
24.25 G 2.27 20.95, 31.08
16 32 17
4 13 4
4 5 5
8 14 8
.75
.67 .64
IOL Z intraocular lens; n Z number of eyes
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IOL TILT AFTER INTRASCLERAL FIXATION
Figure 1. Maximum degree of IOL tilt by sclerotomy size after intrascleral IOL fixation. The value in eyes having intracapsular IOL implantation is shown as a reference. Data are presented as the mean G standard deviation (G Z gauge; IOL Z intraocular lens).
visual acuity, preoperative IOP, postoperative IOP, and frequency of postoperative complications between the sclerotomy groups (24-gauge, 27-gauge, and 30-gauge). Values are presented as the mean G SD, and P values less than 0.05 were considered statistically significant.
RESULTS Table 1 shows the characteristics of the 65 eyes of 60 patients overall and by sclerotomy group. There were no statistically significant differences in age, sex, axial length, corneal diameter, baseline refraction, or preoperative diagnosis between the 3 sclerotomy groups. Figure 1 shows the mean maximum degree of IOL tilt by sclerotomy group. It also shows the value in the 20 eyes that intracapsular IOL fixation to serve as a reference. The mean in eyes having sclerotomy was 8.13 G 5.15 degrees overall and 5.50 G 3.41 degrees, 7.38 G 3.57 degrees, and 10.22 G 5.85 degrees in the 24-gauge group, 27-gauge group, and 30-gauge group, respectively. The mean maximum degree of IOL tilt was significantly smaller in the 24-gauge group than in the 30-gauge group (P Z .003). At 3 months, the mean IOL astigmatism (total
Figure 3. Relationship between maximum degree of IOL tilt and IOL astigmatism after intrascleral IOL fixation (IOL Z intraocular lens). Volume 45 Issue 10 October 2019
Figure 2. Intraocular lens astigmatism by sclerotomy size after intrascleral IOL fixation. Data are presented as mean G standard deviation (G Z gauge; IOL Z intraocular lens).
astigmatism corneal astigmatism) was 0.43 G 0.32 diopter (D), 0.84 G 0.49 D, and 0.85 G 0.77 D, respectively (Figure 2). The mean IOL astigmatism was significantly smaller in the 24-gauge group than in the 27-gauge group (P Z 0.04). Figure 3 shows the association between the maximum degree of IOL tilting and the IOL astigmatism after surgery. The maximum degree of IOL tilt was significantly correlated with the amount of postoperative IOL astigmatism (P Z .0001, R2 Z 0.23). Furthermore, neither axial length (P Z .57, R2 Z 0.0052) nor corneal diameter (P Z .74, R2 Z 0.0021) significantly influenced the degree of IOL tilt. No statistically significant correlation was found between IOL power and IOL tilt (P Z .30, R2 Z 0.018) or IOL astigmatism (P Z .17, R2 Z 0.034). Table 2 shows the changes in visual acuity and astigmatism from preoperatively to postoperatively. The change in CDVA from baseline was statistically significant 1 month, 3 months, and 6 months after surgery (P Z .0039, P Z .0005, and P Z .0011, respectively). There were no statistically significant differences in the mean visual acuity or mean total astigmatism between the sclerotomy groups at any timepoint. The mean IOL astigmatism was greater in the 30-gauge group than in the 24-gauge and 27-gauge groups; however, the differences were not statistically significant. There were no statistically significant differences in refractive power from 3 months after surgery. The mean preoperative IOP was 17.4 G 9.4 mm Hg, which decreased postoperatively to 12.2 G 6.6 mm Hg, 13.0 G 4.3 mm Hg, and 12.4 G 3.4 mm Hg at 1 week, 3 months, and 6 months, respectively. Figure 4 shows the changes in IOP from preoperatively to postoperatively by sclerotomy group. There were no significant betweengroup differences at any timepoint. No complications, such as peripheral retinal breaks and expulsive hemorrhage, were observed during surgery. The most common postoperative complication was transient hypotony (IOP %5 mm Hg) followed by vitreous hemorrhage in (Table 3). The IOP recovered within 2 weeks without additional treatment in all eyes with hypotony. No statistically significant differences were found in the
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Table 2. Change in visual acuity and astigmatism from over time. Mean ± SD Postoperative Parameter/Group CDVA (logMAR) All eyes 24-gauge 27-gauge 30-gauge Total astigmatism (D) All eyes 24-gauge 27-gauge 30-gauge IOL astigmatism (D)* All eyes 24-gauge 27-gauge 30-gauge
Preoperative
1 Month
3 Months
6 Months
0.71 G 0.72 0.99 G 0.81 0.38 G 0.36 0.66 G 0.70
0.47 G 0.51 0.50 G 0.40 0.34 G 0.43 0.50 G 0.58
0.41 G 0.56 0.37 G 0.38 0.27 G 0.45 0.51 G 0.70
0.39 G 0.58 0.39 G 0.42 0.23 G 0.38 0.48 G 0.71
2.24 G 1.84 2.03 G 1.68 2.62 G 2.11 2.20 G 1.73
2.09 G 1.32 1.70 G 1.13 1.96 G 1.18 2.43 G 1.41
1.77 G 1.22 1.41 G 1.08 1.77 G 1.16 2.07 G 1.25
1.95 G 1.39 1.46 G 0.76 1.68 G 1.04 2.42 G 1.76
NA NA NA NA
1.00 G 1.03 0.66 G 1.07 1.18 G 1.03 1.14 G 1.19
0.70 G 0.62 0.43 G 0.32 0.84 G 0.49 0.85 G 0.77
0.72 G 0.75 0.50 G 0.56 0.66 G 0.46 0.90 G 0.90
CDVA Z corrected distance visual acuity; IOL Z intraocular lens; logMAR Z logarithm of the minimum angle of resolution; NA Z not applicable *Total astigmatism corneal astigmatism
incidence of postoperative transient hypotony between the 3 sclerotomy groups. Vitreous hemorrhage resolved spontaneously within 1 week in all cases. The case of IOP elevation (O25 mm Hg) was the result of pigment dispersion and resolved with eyedrop treatment. Iris capture by the IOL was successfully released using a mydriatic agent. Cystoid macular edema resolved after treatment with nonsteroidal antiinflammatory eyedrops. In cases of IOL lens dislocation and IOL haptic protrusion the scleral tunnel, the IOL was immediately repositioned in an additional surgery. No other complications (eg, retinal detachment, endophthalmitis, inflammation of the sclera or conjunctiva) occurred during the follow-up. DISCUSSION In the present study, we assessed whether postoperative visual acuity and IOL tilt were affected by the size of the
sclerotomy. The maximum degree of IOL tilt after intrascleral IOL fixation tends to increase as the sclerotomy size decreases. Postoperatively, the maximum degree of IOL tilt in the 30-gauge group was significantly larger than in the 24-gauge group (P Z .003). The degree of IOL tilt was significantly associated with the amount of postoperative IOL astigmatism (P Z .0001, R2 Z 0.23). No statistically significant differences were found in the preoperative CDVA, postoperative CDVA, or incidence of complications between the 3 sclerotomy groups (24gauge, 27-gauge, and 30-gauge). The results suggest that a tight sclerotomy with a small incision during intrascleral IOL fixation increases the degree of IOL tilt after surgery. Sutureless intrascleral IOL fixation reportedly results in less postoperative IOL tilt and astigmatism than conventional transscleral suturing of the IOL.10 Because a high degree of IOL tilt increases the incidence of astigmatism and coma aberration,23,24 a small degree of or no tilt should be the goal. In the present study, we found that small sclerotomies cause postoperative IOL tilt and astigmatism after intrascleral IOL fixation; to our knowledge, we are the first to
Table 3. Postoperative complications after intrascleral IOL fixation. Complication
Figure 4. Changes in IOP before and after intrascleral intraocular lens fixation by sclerotomy size. Data are presented as mean G standard deviation (G Z gauge; IOP Z intraocular pressure).
Eyes, n (%)
Hypotony (IOP %5 mm Hg) Vitreous hemorrhage IOP elevation (O25 mm Hg) Iris capture of IOL Cystoid macular edema IOL dislocation IOL haptic protrusion from scleral tunnel
11 (16.9) 3 (4.6) 1 (1.5) 1 (1.5) 1 (1.5) 1 (1.5) 1 (1.5)
IOL Z intraocular lens; IOP Z intraocular pressure
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IOL TILT AFTER INTRASCLERAL FIXATION
report this. The reason for this finding might be that distortion of the IOL haptics at the region that penetrates the sclera causes the IOL optic to tilt. In cases of tight sclerotomies, the natural curve of the IOL haptics is forcibly changed. The resulting torsion might cause postoperative IOL tilt. Dislocation of the crystalline lens and IOL causes visual disturbances. In all our cases, the CDVA improved after intrascleral IOL fixation, results that are similar to those of previous reports.11,13,14 The size of the sclerotomy is associated with the amount of IOL tilt and astigmatism; however, no significant difference in the postoperative CDVA was found between our 3 sclerotomy groups. These findings suggest that postoperative IOL astigmatism is mild and can be corrected with spectacle use and that it does not influence the CDVA. Similar to findings in a previous study,10 the value of the IOL astigmatism itself after sutureless intrascleral IOL fixation was small compared with that after transscleral suturing of the IOL. Nevertheless, residual astigmatism after surgery should be minimal to achieve an improvement in vision quality, including freedom from wearing spectacles. Reduced IOL tilt and astigmatism are especially important when a multifocal IOL is used for intrascleral IOL fixation.25 Although postoperative hypotony has been reported previously,13 all reported complications were transient. Hypotony appears to be associated with leakage of intraocular fluid from the sclerotomy incision sites. Smaller sclerotomies might be advantageous because they could hinder leakage from the scleral incision and hypotony. However, we found no statistically significant difference in postoperative IOP between our 3 sclerotomy groups. Leakage from the incision site appears to be transient because 24-gauge incisions might be small enough to seal the wound. Conversely, a significant drop in IOP occurred from preoperatively to postoperatively. Because the status of subluxated crystalline lenses or IOL dislocation can elevate IOP,26,27 IOL fixation might have improved the postoperative IOP. Iris capture by the IOL optic is a frequent postoperative complication after intrascleral IOL fixation; however, it was rare in our study (1.5%), which is in agreement with the results reported by Scharioth et al.13 Although iridotomy can effectively prevent iris capture, iris capture has been reported to occur after iridotomy (8.6%).11 The reason for the low incidence of iris capture in the present study remains unclear. The occurrence of iris capture seems to be influenced by factors such as iris mobility, pupil diameter, and pupil firmness, which are related to the amount of residual ciliary zonule and vitreous body or the presence of exfoliation. The patients’ background might have contributed to the low incidence of iris capture. This study has limitations. First, it was retrospective and had a short follow-up. A longer follow-up is needed to assess IOL stability after intrascleral fixation. Second, it is still unknown whether other intrascleral IOL fixation techniques, such as flanged intrascleral IOL fixation,20 provides
Volume 45 Issue 10 October 2019
similar results; this technique is less invasive than that used in our study because of the smaller conjunctival incision. In conclusion, the 24-, 27-, and 30-gauge sclerotomy sizes for intrascleral IOL fixation did not result in differences in surgical complications. The 24-gauge sclerotomy yielded better IOL tilt and IOL astigmatism outcomes than the 30-gauge sclerotomy and 27-gauge sclerotomy, respectively. Our data suggest that using a sclerotomy smaller than 24 gauge might result in unexpected IOL tilt and astigmatism, despite the lack of the decreased frequency of postoperative complications.
WHAT WAS KNOWN Sutureless intrascleral intraocular lens (IOL) fixation is a useful for IOL implantation in the absence of capsule support.
WHAT THIS PAPER ADDS Sclerotomies smaller than 24 gauge might result in unexpected IOL tilt and astigmatism after intrascleral IOL fixation with lamellar scleral dissection and embedding the haptics in a scleral tunnel.
REFERENCES 1. Zeh WG, Price FW Jr. Iris fixation of posterior chamber intraocular lenses. J Cataract Refract Surg 2000; 26:1028–1034 2. Por YM, Lavin MJ. Techniques of intraocular lens suspension in the absence of capsular/zonular support. Surv Ophthalmol 2005; 50:429–462 3. Azar DT, Wiley WF. Double-knot transscleral suture fixation technique for displaced intraocular lenses. Am J Ophthalmol 1999; 128:644–646 4. Chang S, Coll GE. Surgical techniques for repositioning a dislocated intraocular lens, repair of iridodialysis, and secondary intraocular lens implantation using innovative 25-gauge forceps. Am J Ophthalmol 1995; 119:165–174 5. Kokame GT, Yamamoto I, Mandel H. Scleral fixation of dislocated posterior chamber intraocular lenses; temporary haptic externalization through a clear corneal incision. J Cataract Refract Surg 2004; 30:1049–1056 6. Koh HJ, Kim CY, Lim SJ, Kwon OW. Scleral fixation technique using 2 corneal tunnels for a dislocated intraocular lens. J Cataract Refract Surg 2000; 26:1439–1441 7. Gabor SGB, Pavlidis MM. Sutureless intrascleral posterior chamber intraocular lens fixation. J Cataract Refract Surg 2007; 33:1851–1854 8. Agarwal A, Kumar DA, Jacob S, Baid C, Agarwal A, Srinivasan S. Fibrin glue–assisted sutureless posterior chamber intraocular lens implantation in eyes with deficient posterior capsules. J Cataract Refract Surg 2008; 34:1433–1438 9. Totan Y, Karadag R. Trocar-assisted sutureless intrascleral posterior chamber foldable intra-ocular lens fixation. Eye 2012; 26:788–791 10. Ohta T, Toshida H, Murakami A. Simplified and safe method of sutureless intrascleral posterior chamber intraocular lens fixation: Y-fixation technique. J Cataract Refract Surg 2014; 40:2–7 11. Yamane S, Inoue M, Arakawa A, Kadonosono K. Sutureless 27-gauge needle–guided intrascleral intraocular lens implantation with lamellar scleral dissection. Ophthalmology 2014; 121:61–66 12. Takayama K, Akimoto M, Taguchi H, Nakagawa S, Hiroi K. Transconjunctival sutureless intrascleral intraocular lens fixation using intrascleral tunnels guided with catheter and 30-gauge needles. Br J Ophthalmol 2015; 99:1457–1459 13. Scharioth GB, Prasad S, Georgalas I, Tataru C, Pavlidis M. Intermediate results of sutureless intrascleral posterior chamber intraocular lens fixation. J Cataract Refract Surg 2010; 36:254–259 14. Kumar DA, Agarwal A, Packiyalakshmi S, Jacob S, Agarwal A. Complications and visual outcomes after glued foldable intraocular lens implantation in eyes with inadequate capsules. J Cataract Refract Surg 2013; 39:1211– 1218
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15. Matsui Y, Matsubara H, Hanemoto T, Kondo M. Exposure of haptic of posterior chamber intraocular lens after sutureless intrascleral fixation. BMC Ophthalmol 2015; 15:104 16. McAllister AS, Hirst LW. Visual outcomes and complications of scleralfixated posterior chamber intraocular lenses. J Cataract Refract Surg 2011; 37:1263–1269 17. Teichmann KD, Teichmann IAM. The torque and tilt gamble. J Cataract Refract Surg 1997; 23:413–418 18. Solomon K, Gussler JR, Gussler C, Van Meter WS. Incidence and management of complications of transsclerally sutured posterior chamber lenses. J Cataract Refract Surg 1993; 19:488–493 19. Akimoto M, Taguchi H, Takayama K, Nakagawa S, Hiroi K. Intrascleral fixation technique using catheter needles and 30-gauge ultrathin needles: lock-and-lead technique. J Cataract Refract Surg 2015; 41:257–261 20. Yamane S, Sato S, Maruyama-Inoue M, Kadonosono K. Flanged intrascleral intraocular lens fixation with double-needle technique. Ophthalmology 2017; 124:1136–1142 21. Rodríguez-Agirretxe I, Acera-Osa A, Ubeda-Erviti M. Needle-guided intrascleral fixation of posterior chamber intraocular lens for aphakia correction. J Cataract Refract Surg 2009; 35:2051–2053 22. Kimura S, Morizane Y, Shiode Y, Hirano M, Doi S, Toshima S, Fujiwara A, Shiraga F. Assessment of tilt and decentration of crystalline lens and intraocular lens relative to the corneal topographic axis using anterior segment optical coherence tomography. PLoS One 2017; 12 (9):e0184066 23. Taketani F, Matsuura T, Yukawa E, Hara Y. Influence of intraocular lens tilt and decentration on wavefront aberrations. J Cataract Refract Surg 2004; 30:2158–2162
24. Oshika T, Sugita G, Miyata K, Tokunaga T, Samejima T, Okamoto C, Ishii Y. Influence of tilt and decentration of scleral-sutured intraocular lens on ocular higher-order wavefront aberration. Br J Ophthalmol 2007; 91:185–188 25. Pavlidis M, de Ortueta D, Scharioth GB. Bioptics in sutureless intrascleral multifocal posterior chamber intraocular lens fixation. J Refract Surg 2011; 27:386–388 26. Inatani M, Tanihara H, Honjo M, Kido N, Honda Y. Secondary glaucoma associated with crystalline lens subluxation. J Cataract Refract Surg 2000; 26:1533–1536 27. Lorente Bulnes B, de Rojas Silva MV, Lorente Moore R. Intraocular pressure changes before and after surgery for spontaneous in-the-bag intraocular lens dislocation. J Cataract Refract Surg 2019; 45:305–311
Disclosures: None of the authors has a financial or proprietary interest in any material or method mentioned.
First author: Takehiro Matsumura, MD, PhD Department of Ophthalmology, Faculty of Medical Sciences, University of Fukui, Japan
Volume 45 Issue 10 October 2019
ARTICLE
Influence of sclerotomy size on intraocular lens tilt after intrascleral intraocular lens fixation Takehiro Matsumura, MD, PhD, Yoshihiro Takamura, MD, PhD, Jun Makita, MD, PhD, Akira Kobori, MD, Masaru Inatani, MD, PhD
Purpose: To determine whether differences in sclerotomy size
Results: The study included 65 eyes (60 patients). Postopera-
during intrascleral intraocular lens (IOL) fixation influence IOL tilt and visual acuity after surgery.
tively, the maximum degree of IOL tilt was significantly smaller in the 24-gauge sclerotomy group than in the 30-gauge sclerotomy group (P Z .003). The degree of IOL tilt was significantly correlated with the amount of postoperative IOL astigmatism (total astigmatism corneal astigmatism) (P Z .0001, R2 Z 0.23). There were no statistically significant differences in the preoperative or postoperative corrected distance visual acuity (CDVA) or the complication rate between the sclerotomy groups.
Setting: University of Fukui Hospital and Japanese Red Cross Fukui Hospital, Japan.
Design: Retrospective case series. Methods: The study reviewed the records of patients who had intrascleral IOL fixation with transconjunctival 25-gauge pars plana vitrectomy and a follow-up longer than 6 months. The preoperative and postoperative visual outcomes, degree of IOL tilt, and intraoperative and postoperative complications were statistically compared between the sclerotomy groups.
I
n eyes without sufficient posterior capsule support, an intraocular lens (IOL) can be implanted in the anterior chamber, fixated to the iris, or transsclerally fixated through the ciliary sulcus or pars plana.1–6 To date, a transscleral sutured posterior chamber IOL has primarily been used in the transscleral fixation technique.2–6 Recently, sutureless intrascleral IOL fixation has become popular; however, the long-term outcomes of this approach remain unclear.7–15 Compared with conventional transscleral suturing of an IOL, sutureless intrascleral IOL fixation has benefits, such as tight fixation of the IOL haptics inserted in the scleral tunnels, no suture breakage,16 and a lower incidence of IOL decentration,17 vitreous hemorrhage,18 and endophthalmitis resulting from suture exposure. Several improved techniques, such as the glued-IOL method,8 Y-fixation method,10 and double-needle
Conclusion: A smaller sclerotomy for intrascleral IOL fixation was associated with greater IOL tilt and IOL astigmatism after surgery; however, this did not clinically or significantly affect the postoperative CDVA. J Cataract Refract Surg 2019; 45:1446–1451 Q 2019 ASCRS and ESCRS
method,11 have been reported for fixation of IOL haptics. However, haptic fixation with the intrascleral technique differs from that with other IOL haptic fixation methods.7,8,10–12,19,20 In particular, the techniques of lamellar scleral dissection and for creating a scleral tunnel for embedding IOL haptics allow the surgeon to pull out and fix the haptics in a simple and safe manner.10,11 In intrascleral IOL fixation, sclerotomies are created using a 20-, 22-, 23-, 24-, 25-, 27-, or 30-gauge needle.7–11,14,19,21 Small sclerotomies are expected to reduce the incidence of postoperative complications, such as hypotony or ciliary body injury.11 However, it remains unknown whether the postoperative visual acuity and IOL stability are affected by the size of the sclerotomy. Therefore, we sought to determine whether sclerotomy size influences postoperative visual acuity and IOL tilt.
Submitted: April 23, 2019 | Final revision submitted: June 9, 2019 | Accepted: June 11, 2019 From the Departments of Ophthalmology, Faculty of Medical Sciences, University of Fukui (Matsumura, Takamura, Inatani), Tokyo Dental College Ichikawa General Hospital (Matsumura), Chiba, Saitama Medical University Hospital (Makita), and Japanese Red Cross Fukui Hospital (Kobori), Fukui, Japan. Supported in part by Grants-in-Aid for Scientific Research (#18K16951), Japan Society for the Promotion of Science, Tokyo. Corresponding author: Yoshihiro Takamura, MD, PhD, Department of Ophthalmology, Faculty of Medical Sciences, University of Fukui, 23-3 Shimoaizuki, Matsuoka, Eiheiji, Fukui, 910-1193, Japan. Email: [email protected]. Q 2019 ASCRS and ESCRS Published by Elsevier Inc.
0886-3350/$ - see frontmatter https://doi.org/10.1016/j.jcrs.2019.06.006
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PATIENTS AND METHODS This retrospective interventional case series reviewed data from the University of Fukui Hospital and Japanese Red Cross Fukui Hospital. The study was approved by the University of Fukui Hospital Institutional Review Board (approval #20180037) and was performed in accordance with the tenets of the Declaration of Helsinki. The medical records of consecutive patients who had intrascleral IOL fixation with transconjunctival 25-gauge pars plana vitrectomy between April 1, 2012, and December 31, 2017 were retrospectively assessed. The study protocol was disclosed, and the patients were given the opportunity to refuse to participate in the study. The inclusion criteria were as follows: at least 20 years of age, treatment with intrascleral IOL fixation for aphakia, a subluxated crystalline lens or a dislocated IOL, and a postoperative follow-up longer than 6 months. The exclusion criteria were retinal disease requiring treatment (eg, retinal detachment or vitreous hemorrhage) and scleritis. Also excluded were patients who did not agree to follow the study protocol. The information collected retrospectively from the medical records included age, sex, preoperative lens status, axial length, corneal diameter, preoperative and postoperative refractive power, corrected distance visual acuity (CDVA), intraocular pressure (IOP), degree of IOL tilt, IOL power, sclerotomy size, and intraoperative and postoperative complications. Postoperative hypotony and IOP elevation were defined as an IOP less than 6 mm Hg and an IOP greater than 25 mm Hg, respectively. Surgical Technique Intrascleral IOL fixation was performed as previously described10,11 with some modifications. A 25-gauge pars plana vitrectomy was performed using the Constellation Vision System (Alcon Laboratories, Inc.) under retrobulbar anesthesia. Phacoemulsification was performed for subluxated crystalline lenses; a vitrectomy cutter was used if part of the crystalline lens fell into the vitreous cavity. If the dislocated IOL was made of a soft material, it was cut into 2 or 3 pieces and extruded through the 3.0 mm sclerocorneal incision. Dislocated poly(methyl methacrylate) IOLs were extruded through the 6.0 mm sclerocorneal incision. Two T-shaped lamellar scleral incisions were created 2.0 mm from the limbus exactly 180 degrees apart diagonally. Scleral tunnels were made parallel to the limbus at the branching point of the
T-shaped incision. The sclerotomy was made at the T-shaped incision with a 24-gauge angled microvitreoretinal knife, or an angled sclerotomy was made with a 27-gauge or 30-gauge needle. A 3-piece IOL (X-70 or NX-70, Santen Pharmaceutical Co., Ltd.) was implanted in the anterior chamber with an injector; the trailing haptic was kept outside to prevent the IOL from falling into the vitreous cavity. Both haptics were grasped with a forceps and pulled through the sclerotomy or externalized onto the sclera using the double-needle technique. The ends of the haptics were subsequently inserted into the limbus-parallel scleral tunnels with a forceps, after which the IOL was centered. A peripheral iridotomy was performed using the vitrectomy cutter after miosis to prevent reverse iris block and iris capture of the IOL. A single 9-0 nylon suture was used to fixate the haptic to the scleral bed. Wounds were not sutured if there was no leakage from the sclerotomy. The infusion cannula was removed after IOL fixation. Intraocular Lens Tilt Measurements Three months after surgery, the angle of IOL tilt was measured with swept-source optical coherence tomography (SS-1000 CASIA, Tomey Corp.) using a standardized radial scan performed after pupil dilation. The visual line passing through the cornea to the pupil was used as the reference line.22 The angle between the reference line and the horizontal axis of the IOL was taken as the IOL tilt. The radial scan acquired 512 A/B-scan images, each containing 128 B/C scans with a length of 16.0 mm. The IOL tilt was measured using the radial scan images. The maximum angle of IOL tilt was determined over all the radial scan images and was defined as the maximum degree of IOL tilt. For comparison, the degree of IOL tilt with intracapsular fixation was measured in 20 patients who had phacoemulsification and 25-gauge pars plana vitrectomy to treat cataract and epiretinal membrane. Statistical Analysis Statistical analyses were performed using JMP software (version 10, SAS Institute, Inc.). The CDVA was recorded in decimal units and then converted to logarithm of the minimum angle of resolution notation for statistical analysis. The Wilcoxon signed-rank test was used to compare the preoperative CDVA and postoperative CDVA. The Tukey-Kramer test was used to compare the mean maximum degree of IOL tilt, changes in refractive power,
Table 1. Patient demographic data. Characteristic Eyes (n) Age (y) Mean G SD Range Sex, n (%) Male Female Surgical eye Right Left Axial length (mm) Mean G SD Range Diagnosis (n) Subluxated crystalline lens Dislocated IOL Aphakia
Total
24-Gauge
27-Gauge
30-Gauge
P Value
65
21
14
30
d
70.9 G 14.7 21, 92
67.9 G 18.4 21, 89
66.3 G 14.6 38, 82
75.3 G 10.5 49, 92
.08 .87
43 (66) 22 (34)
14 (67) 7 (33)
10 (71) 4 (29)
19 (63) 11 (37)
29 36
10 11
5 9
14 16
24.36 G 2.34 20.95, 32.64
24.72 G 2.69 21.74, 32.64
24.05 G 1.99 21.74, 28.28
24.25 G 2.27 20.95, 31.08
16 32 17
4 13 4
4 5 5
8 14 8
.75
.67 .64
IOL Z intraocular lens; n Z number of eyes
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Figure 1. Maximum degree of IOL tilt by sclerotomy size after intrascleral IOL fixation. The value in eyes having intracapsular IOL implantation is shown as a reference. Data are presented as the mean G standard deviation (G Z gauge; IOL Z intraocular lens).
visual acuity, preoperative IOP, postoperative IOP, and frequency of postoperative complications between the sclerotomy groups (24-gauge, 27-gauge, and 30-gauge). Values are presented as the mean G SD, and P values less than 0.05 were considered statistically significant.
RESULTS Table 1 shows the characteristics of the 65 eyes of 60 patients overall and by sclerotomy group. There were no statistically significant differences in age, sex, axial length, corneal diameter, baseline refraction, or preoperative diagnosis between the 3 sclerotomy groups. Figure 1 shows the mean maximum degree of IOL tilt by sclerotomy group. It also shows the value in the 20 eyes that intracapsular IOL fixation to serve as a reference. The mean in eyes having sclerotomy was 8.13 G 5.15 degrees overall and 5.50 G 3.41 degrees, 7.38 G 3.57 degrees, and 10.22 G 5.85 degrees in the 24-gauge group, 27-gauge group, and 30-gauge group, respectively. The mean maximum degree of IOL tilt was significantly smaller in the 24-gauge group than in the 30-gauge group (P Z .003). At 3 months, the mean IOL astigmatism (total
Figure 3. Relationship between maximum degree of IOL tilt and IOL astigmatism after intrascleral IOL fixation (IOL Z intraocular lens). Volume 45 Issue 10 October 2019
Figure 2. Intraocular lens astigmatism by sclerotomy size after intrascleral IOL fixation. Data are presented as mean G standard deviation (G Z gauge; IOL Z intraocular lens).
astigmatism corneal astigmatism) was 0.43 G 0.32 diopter (D), 0.84 G 0.49 D, and 0.85 G 0.77 D, respectively (Figure 2). The mean IOL astigmatism was significantly smaller in the 24-gauge group than in the 27-gauge group (P Z 0.04). Figure 3 shows the association between the maximum degree of IOL tilting and the IOL astigmatism after surgery. The maximum degree of IOL tilt was significantly correlated with the amount of postoperative IOL astigmatism (P Z .0001, R2 Z 0.23). Furthermore, neither axial length (P Z .57, R2 Z 0.0052) nor corneal diameter (P Z .74, R2 Z 0.0021) significantly influenced the degree of IOL tilt. No statistically significant correlation was found between IOL power and IOL tilt (P Z .30, R2 Z 0.018) or IOL astigmatism (P Z .17, R2 Z 0.034). Table 2 shows the changes in visual acuity and astigmatism from preoperatively to postoperatively. The change in CDVA from baseline was statistically significant 1 month, 3 months, and 6 months after surgery (P Z .0039, P Z .0005, and P Z .0011, respectively). There were no statistically significant differences in the mean visual acuity or mean total astigmatism between the sclerotomy groups at any timepoint. The mean IOL astigmatism was greater in the 30-gauge group than in the 24-gauge and 27-gauge groups; however, the differences were not statistically significant. There were no statistically significant differences in refractive power from 3 months after surgery. The mean preoperative IOP was 17.4 G 9.4 mm Hg, which decreased postoperatively to 12.2 G 6.6 mm Hg, 13.0 G 4.3 mm Hg, and 12.4 G 3.4 mm Hg at 1 week, 3 months, and 6 months, respectively. Figure 4 shows the changes in IOP from preoperatively to postoperatively by sclerotomy group. There were no significant betweengroup differences at any timepoint. No complications, such as peripheral retinal breaks and expulsive hemorrhage, were observed during surgery. The most common postoperative complication was transient hypotony (IOP %5 mm Hg) followed by vitreous hemorrhage in (Table 3). The IOP recovered within 2 weeks without additional treatment in all eyes with hypotony. No statistically significant differences were found in the
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Table 2. Change in visual acuity and astigmatism from over time. Mean ± SD Postoperative Parameter/Group CDVA (logMAR) All eyes 24-gauge 27-gauge 30-gauge Total astigmatism (D) All eyes 24-gauge 27-gauge 30-gauge IOL astigmatism (D)* All eyes 24-gauge 27-gauge 30-gauge
Preoperative
1 Month
3 Months
6 Months
0.71 G 0.72 0.99 G 0.81 0.38 G 0.36 0.66 G 0.70
0.47 G 0.51 0.50 G 0.40 0.34 G 0.43 0.50 G 0.58
0.41 G 0.56 0.37 G 0.38 0.27 G 0.45 0.51 G 0.70
0.39 G 0.58 0.39 G 0.42 0.23 G 0.38 0.48 G 0.71
2.24 G 1.84 2.03 G 1.68 2.62 G 2.11 2.20 G 1.73
2.09 G 1.32 1.70 G 1.13 1.96 G 1.18 2.43 G 1.41
1.77 G 1.22 1.41 G 1.08 1.77 G 1.16 2.07 G 1.25
1.95 G 1.39 1.46 G 0.76 1.68 G 1.04 2.42 G 1.76
NA NA NA NA
1.00 G 1.03 0.66 G 1.07 1.18 G 1.03 1.14 G 1.19
0.70 G 0.62 0.43 G 0.32 0.84 G 0.49 0.85 G 0.77
0.72 G 0.75 0.50 G 0.56 0.66 G 0.46 0.90 G 0.90
CDVA Z corrected distance visual acuity; IOL Z intraocular lens; logMAR Z logarithm of the minimum angle of resolution; NA Z not applicable *Total astigmatism corneal astigmatism
incidence of postoperative transient hypotony between the 3 sclerotomy groups. Vitreous hemorrhage resolved spontaneously within 1 week in all cases. The case of IOP elevation (O25 mm Hg) was the result of pigment dispersion and resolved with eyedrop treatment. Iris capture by the IOL was successfully released using a mydriatic agent. Cystoid macular edema resolved after treatment with nonsteroidal antiinflammatory eyedrops. In cases of IOL lens dislocation and IOL haptic protrusion the scleral tunnel, the IOL was immediately repositioned in an additional surgery. No other complications (eg, retinal detachment, endophthalmitis, inflammation of the sclera or conjunctiva) occurred during the follow-up. DISCUSSION In the present study, we assessed whether postoperative visual acuity and IOL tilt were affected by the size of the
sclerotomy. The maximum degree of IOL tilt after intrascleral IOL fixation tends to increase as the sclerotomy size decreases. Postoperatively, the maximum degree of IOL tilt in the 30-gauge group was significantly larger than in the 24-gauge group (P Z .003). The degree of IOL tilt was significantly associated with the amount of postoperative IOL astigmatism (P Z .0001, R2 Z 0.23). No statistically significant differences were found in the preoperative CDVA, postoperative CDVA, or incidence of complications between the 3 sclerotomy groups (24gauge, 27-gauge, and 30-gauge). The results suggest that a tight sclerotomy with a small incision during intrascleral IOL fixation increases the degree of IOL tilt after surgery. Sutureless intrascleral IOL fixation reportedly results in less postoperative IOL tilt and astigmatism than conventional transscleral suturing of the IOL.10 Because a high degree of IOL tilt increases the incidence of astigmatism and coma aberration,23,24 a small degree of or no tilt should be the goal. In the present study, we found that small sclerotomies cause postoperative IOL tilt and astigmatism after intrascleral IOL fixation; to our knowledge, we are the first to
Table 3. Postoperative complications after intrascleral IOL fixation. Complication
Figure 4. Changes in IOP before and after intrascleral intraocular lens fixation by sclerotomy size. Data are presented as mean G standard deviation (G Z gauge; IOP Z intraocular pressure).
Eyes, n (%)
Hypotony (IOP %5 mm Hg) Vitreous hemorrhage IOP elevation (O25 mm Hg) Iris capture of IOL Cystoid macular edema IOL dislocation IOL haptic protrusion from scleral tunnel
11 (16.9) 3 (4.6) 1 (1.5) 1 (1.5) 1 (1.5) 1 (1.5) 1 (1.5)
IOL Z intraocular lens; IOP Z intraocular pressure
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report this. The reason for this finding might be that distortion of the IOL haptics at the region that penetrates the sclera causes the IOL optic to tilt. In cases of tight sclerotomies, the natural curve of the IOL haptics is forcibly changed. The resulting torsion might cause postoperative IOL tilt. Dislocation of the crystalline lens and IOL causes visual disturbances. In all our cases, the CDVA improved after intrascleral IOL fixation, results that are similar to those of previous reports.11,13,14 The size of the sclerotomy is associated with the amount of IOL tilt and astigmatism; however, no significant difference in the postoperative CDVA was found between our 3 sclerotomy groups. These findings suggest that postoperative IOL astigmatism is mild and can be corrected with spectacle use and that it does not influence the CDVA. Similar to findings in a previous study,10 the value of the IOL astigmatism itself after sutureless intrascleral IOL fixation was small compared with that after transscleral suturing of the IOL. Nevertheless, residual astigmatism after surgery should be minimal to achieve an improvement in vision quality, including freedom from wearing spectacles. Reduced IOL tilt and astigmatism are especially important when a multifocal IOL is used for intrascleral IOL fixation.25 Although postoperative hypotony has been reported previously,13 all reported complications were transient. Hypotony appears to be associated with leakage of intraocular fluid from the sclerotomy incision sites. Smaller sclerotomies might be advantageous because they could hinder leakage from the scleral incision and hypotony. However, we found no statistically significant difference in postoperative IOP between our 3 sclerotomy groups. Leakage from the incision site appears to be transient because 24-gauge incisions might be small enough to seal the wound. Conversely, a significant drop in IOP occurred from preoperatively to postoperatively. Because the status of subluxated crystalline lenses or IOL dislocation can elevate IOP,26,27 IOL fixation might have improved the postoperative IOP. Iris capture by the IOL optic is a frequent postoperative complication after intrascleral IOL fixation; however, it was rare in our study (1.5%), which is in agreement with the results reported by Scharioth et al.13 Although iridotomy can effectively prevent iris capture, iris capture has been reported to occur after iridotomy (8.6%).11 The reason for the low incidence of iris capture in the present study remains unclear. The occurrence of iris capture seems to be influenced by factors such as iris mobility, pupil diameter, and pupil firmness, which are related to the amount of residual ciliary zonule and vitreous body or the presence of exfoliation. The patients’ background might have contributed to the low incidence of iris capture. This study has limitations. First, it was retrospective and had a short follow-up. A longer follow-up is needed to assess IOL stability after intrascleral fixation. Second, it is still unknown whether other intrascleral IOL fixation techniques, such as flanged intrascleral IOL fixation,20 provides
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similar results; this technique is less invasive than that used in our study because of the smaller conjunctival incision. In conclusion, the 24-, 27-, and 30-gauge sclerotomy sizes for intrascleral IOL fixation did not result in differences in surgical complications. The 24-gauge sclerotomy yielded better IOL tilt and IOL astigmatism outcomes than the 30-gauge sclerotomy and 27-gauge sclerotomy, respectively. Our data suggest that using a sclerotomy smaller than 24 gauge might result in unexpected IOL tilt and astigmatism, despite the lack of the decreased frequency of postoperative complications.
WHAT WAS KNOWN Sutureless intrascleral intraocular lens (IOL) fixation is a useful for IOL implantation in the absence of capsule support.
WHAT THIS PAPER ADDS Sclerotomies smaller than 24 gauge might result in unexpected IOL tilt and astigmatism after intrascleral IOL fixation with lamellar scleral dissection and embedding the haptics in a scleral tunnel.
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Disclosures: None of the authors has a financial or proprietary interest in any material or method mentioned.
First author: Takehiro Matsumura, MD, PhD Department of Ophthalmology, Faculty of Medical Sciences, University of Fukui, Japan
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