Abstract
Purpose
To determine the risk factors and incidence of cataract formation over a long-term mean follow-up of 7.5 years after type V4 implantable collamer lens (ICL) implantation.
Methods
We analyzed the preoperative, 3-month postoperative, 3-year postoperative, and last follow-up data of 228 eyes (118 patients) with mean preoperative spherical equivalent of -12.7 D and minimum postoperative follow-up of 3 years. Additionally, we determined the risk factors for cataract formation and calculated the 10.3 year cumulative cataract formation rate and 10.3 year cumulative cataract surgery rate using a survival curve.
Results
After type V4 ICL implantation with minimum follow-up of 3 years, the calculated 10.3 year cumulative cataract formation rate was 20% and actual cataracts developed in 34 eyes (14.9%). The 10.3 year cumulative cataract surgery rate was 12% based on a survival curve and actual cataract surgery was performed in 12 eyes (5.3%). The risk factors for cataract formation were age (odds ratio [OR] = 1.10, p = 0.00), preoperative spherical equivalent (OR = 0.90, p = 0.00), crystalline lens thickness (OR = 9.54, p = 0.00), axial length (OR = 1.33, p = 0.00), 3 months postoperative vault (OR = 0.50, p = 0.03), and existence of peripheral touch between ICL optic margin and crystalline lens at last follow-up (OR = 7.84, p = 0.00).
References
1. Sanders DR, Vukich JA, Doney K, et al. U.S. Food and Drug Administration clinical trial of the implantable contact lens for moderate to high myopia. Ophthalmology. 2003; 110:255–66.
2. Sanders DR, Doney K, Poco M; ICL in Treatment of Myopia Study Group. United States Food and Drug Administration clinical trial of the Implantable Collamer Lens (ICL) for moderate to high myopia: three-year follow-up. Ophthalmology. 2004; 111:1683–92.
3. Alfonso JF, Baamonde B, Fernández-Vega L, et al. Posterior chamber collagen copolymer phakic intraocular lenses to correct myopia: five-year follow-up. J Cataract Refract Surg. 2011; 37:873–80.
4. Fernandes P, González-Méijome JM, Madrid-Costa D, et al. Implantable collamer posterior chamber intraocular lenses: a review of potential complications. J Refract Surg. 2011; 27:765–76.
5. Jiménez-Alfaro I, Benítez del Castillo JM, García-Feijoó J, et al. Safety of posterior chamber phakic intraocular lenses for the correction of high myopia: anterior segment changes after posterior chamber phakic intraocular lens implantation. Ophthalmology. 2001; 108:90–9.
6. Pérez-Santonja JJ, Iradier MT, Benítez del Castillo JM, et al. Chronic subclinical inflammation in phakic eyes with intraocular lenses to correct myopia. J Cataract Refract Surg. 1996; 22:183–7.
7. Sanders DR. Anterior subcapsular opacities and cataracts 5 years after surgery in the visian implantable collamer lens FDA trial. J Refract Surg. 2008; 24:566–70.
8. Sanders DR; ICL in Treatment of Myopia Study Group. Postoperative inflammation after implantation of the implantable contact lens. Ophthalmology. 2003; 110:2335–41.
9. Hoffer KJ. Ultrasound axial length measurement in biphakic eyes. J Cataract Refract Surg. 2003; 29:961–5.
10. Sanders DR, Vukich JA; ICL in Treatment of Myopia (ITM) Study Group. Incidence of lens opacities and clinically significant cataracts with the implantable contact lens: comparison of two lens designs. J Refract Surg. 2002; 18:673–82.
11. Kubo E, Kumamoto Y, Tsuzuki S, Akagi Y. Axial length, myopia, and the severity of lens opacity at the time of cataract surgery. Arch Ophthalmol. 2006; 124:1586–90.
12. Jeon S, Kim HS. Clinical characteristics and outcomes of cataract surgery in highly myopic Koreans. Korean J Ophthalmol. 2011; 25:84–9.
13. Younan C, Mitchell P, Cumming RG, et al. Myopia and incident cataract and cataract surgery: the blue mountains eye study. Invest Ophthalmol Vis Sci. 2002; 43:3625–32.
14. Wong TY, Klein BE, Klein R, et al. Refractive errors and incident cataracts: the Beaver Dam Eye Study. Invest Ophthalmol Vis Sci. 2001; 42:1449–54.
15. Leske MC, Wu SY, Nemesure B, et al. Risk factors for incident nuclear opacities. Ophthalmology. 2002; 109:1303–8.
16. Khalifa YM, Moshirfar M, Mifflin MD, et al. Cataract development associated with collagen copolymer posterior chamber phakic intraocular lenses: clinicopathological correlation. J Cataract Refract Surg. 2010; 36:1768–74.
17. Fujisawa K, Shimizu K, Uga S, et al. Changes in the crystalline lens resulting from insertion of a phakic IOL (ICL) into the porcine eye. Graefes Arch Clin Exp Ophthalmol. 2007; 245:114–22.
18. Kawamorita T, Uozato H, Shimizu K. Fluid dynamics simulation of aqueous humour in a posterior-chamber phakic intraocular lens with a central perforation. Graefes Arch Clin Exp Ophthalmol. 2012; 250:935–9.
19. Uozato H, Shimizu K, Kawamorita T, Ohmoto F. Modulation transfer function of intraocular collamer lens with a central artifi-cial hole. Graefes Arch Clin Exp Ophthalmol. 2011; 249:1081–5.
20. Maeng HS, Chung TY, Lee DH, Chung ES. Risk factor evaluation for cataract development in patients with low vaulting after phakic intraocular lens implantation. J Cataract Refract Surg. 2011; 37:881–5.
21. Gonvers M, Bornet C, Othenin-Girard P. Implantable contact lens for moderate to high myopia: relationship of vaulting to cataract formation. J Cataract Refract Surg. 2003; 29:918–24.
22. Schmidinger G, Lackner B, Pieh S, Skorpik C. Long-term changes in posterior chamber phakic intraocular collamer lens vaulting in myopic patients. Ophthalmology. 2010; 117:1506–11.
23. de Castro A, Siedlecki D, Borja D, et al. Age-dependent variation of the Gradient Index profile in human crystalline lenses. Journal of Modern Optics. 2011; 58:1781–7.
24. Nongpiur ME, He M, Amerasinghe N, et al. Lens vault, thickness, and position in Chinese subjects with angle closure. Ophthalmology. 2011; 118:474–9.
25. Oh WH, Kim TW, Park KH, Kim DM. Location of the tube tip in the anterior chamber and change in corneal endothelium after Ahmed valve implantation. J Korean Ophthalmol Soc. 2013; 54:469–74.
26. Takahashi A, Ito Y, Iguchi Y, et al. Axial length increases and related changes in highly myopic normal eyes with myopic complications in fellow eyes. Retina. 2012; 32:127–33.
27. Olsen T, Jeppesen P. The incidence of retinal detachment after cataract surgery. Open Ophthalmol J. 2012; 6:79–82.
28. Ripandelli G, Scassa C, Parisi V, et al. Cataract surgery as a risk factor for retinal detachment in very highly myopic eyes. Ophthalmology. 2003; 110:2355–61.
29. Williams MA, McGimpsey S, Abugreen S, et al. The incidence and rate of rhegmatogenous retinal detachment seven years after cataract surgery in patients with high myopia. Ulster Med J. 2009; 78:99–104.
30. Colin J, Robinet A, Cochener B. Retinal detachment after clear lens extraction for high myopia: seven-year follow-up. Ophthalmology. 1999; 106:2281–4. discussion 2285.
Table 1.
Values are presented as mean ± SD unless otherwise indicated. Age = age at implantable collamer lens implantation; SE = spherical equivalent; IOP = intraocular pressure; LT = crystalline lens thickness; ACD = anterior chamber depth; AXL = axial length; WWD = white to white diameter measured with caliper; CCT = central corneal thickness; BCVA = best corrected visual acuity; UCVA = uncorrected visual acuity.
Table 2.
Time to initial cataract (years) | Range (years) | |
---|---|---|
Group A (n = 13) | 2.6 ± 2.0 | 0.3-4.5 |
Group B (n = 21) | 4.7 ± 1.3 | 0.9-9.1 |
Table 3.
ASCO only | PSCO only | NS only | ASCO + PSCO | ASCO + NS | ASCO +NS + PSCO | NS + PSCO | Total | |
---|---|---|---|---|---|---|---|---|
Group A | 4 | 0 | 1 | 6 | 1 | 1 | 0 | 13 |
Group B | 10 | 4 | 0 | 6 | 0 | 0 | 1 | 21 |
Table 5.
Parameter | Group A + B (34 eyes)(Cataract group) | Group C (194 eyes)(No cataract group) | OR (95% CI) | p-value |
---|---|---|---|---|
Age (years) | 38.0 ± 8.3 | 29.8 ± 7.6 | 1.10 (1.06-1.14) | 0.00 |
Preoperative SE (diopters) | -15.2 ± 4.6 | -12.2 ± 4.2 | 0.90 (0.84-0.96) | 0.00 |
Preoperative LT (mm) | 3.92 ± 0.36 | 3.71 ± 0.26 | 9.54 (3.19-28.51) | 0.00 |
Preoperative AXL (mm) | 29.2 ± 1.70 | 27.9 ± 1.84 | 1.33 (1.13-1.57) | 0.00 |
Vault 3m (CCT) | 1.3 ± 0.6 | 1.5 ± 0.7 | 0.50 (0.27-0.94) | 0.03 |
(range 0-3.0) | (range 0.3-4.0) | |||
Last peripheral touch* (eyes) | 8/34 (24%) | 4/194 (2%) | 7.84 (3.53-17.39) | 0.00 |
Table 6.
Group A + B (Cataract group) | Group C (No cataract group) | |
---|---|---|
Preoperative LT >4 mm (eyes) | 13 (38) | 23 (12) |
Preoperative LT ≤4 mm (eyes) |
21 (62) |
171 (88) |
Total | 34 (100) | 194 (100) |
Table 7.
Group A + B (Cataract group) | Group C (No cataract group) | |
---|---|---|
Preoperative LT >4 mm, Age ≤35 (eyes) | 2 (15) | 11 (48) |
Preoperative LT >4 mm, Age >35 (eyes) |
11 (85) |
12 (52) |
Total | 13 (100) | 23 (100) |
Table 8.
Parameter | Group A (13 eyes) | Group B (21 eyes) | OR (95% CI) | p-value |
---|---|---|---|---|
Vault 3mo (CCT) | 0.9 ± 0.3 (range 0.4-1.3) | 1.5 ± 0.7 (range 0-3.0) | 0.29 (0.11-0.75) | 0.01 |
Last peripheral touch* (eyes) | 6/13 (46%) | 2/21 (10%) | 4.19 (1.27-13.79) | 0.02 |
Table 9.
Table 10.
Adverse event | No. of eyes |
---|---|
Retinal detachment | 2 (0.9) |
Myopic CNV | 3 (1.3) |
Pigment dispersion glaucoma | 2 (0.9) |
Turbid ICL | 2 (0.9) |
Immediate postoperative sterile hypopyon |
2 (0.9) |
Total | 11 (4.8) |