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ICL delivers visual stability, low complication rate at 12 years
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A posterior chamber phakic IOL yielded a low incidence of complications and sustained refractive outcomes and visual stability in the correction of high myopia over the long term, according to a study.
The study, published in the Journal of Refractive Surgery, reported 12-year data on the Implantable Collamer Lens (ICL, STAAR Surgical) and provided information on the evolution, long-term refractive and visual stability, and complications associated with the ICL.
ICL background
To improve visual quality and reduce the incidence of complications that occurred with the initial model, modifications have been made to the ICL, such as adding haptic footplates, a plano-convex optic design of up to 5.5 mm, an additional 0.13 mm to 0.21 mm anterior vault, and a small central hole called KS-AquaPORT.
The cumulative retrospective study included 144 eyes of 86 patients implanted with the ICL for high myopia correction between 1998 and 2001. The ICL V3 was implanted in 15 eyes (11.45%), and the ICL V4 was implanted in 129 eyes (88.55%). At 12 years after implantation, 112 eyes were available for examination.
“Our study highlights some interesting facts such as the low incidence of complications like cataracts, endothelial cell loss and vitreoretinal disease, as well as the good results and great refractive stability in the long term,” Tomás Moya, MD, PhD, told Ocular Surgery News.
Corrected distance visual acuity, uncorrected distance visual acuity, spherical equivalent, refractive astigmatism, endothelial cell density, ICL vaulting and postoperative complications were analyzed.
Visual acuity outcomes
Ten eyes lost two or more lines of corrected distance visual acuity 12 years after ICL implantation due to progressive myopic retinal pigment epithelium alterations without evidence of choroidal neovascularization.
Spherical equivalent was within 1 D of emmetropia in 63.5% of eyes at 1 month, 74.5% of eyes at 1 year and 34.3% of eyes at 12 years. Mean spherical equivalent refraction improved from 16.9 D preoperatively to 1.77 D postoperatively.
Mean corrected distance visual acuity was 0.31 at the first visit and 0.22 at the final visit. The improvement was statistically significant (P < .001).
“The most outstanding outcome has been the gain of uncorrected distance visual acuity, due to the magnifying effect of the retinal image, and the refractive stability in the long term,” Moya said.
Incidence of cataracts
Twenty of the 144 eyes (13.88%) developed significant lens opacity; 11 of those eyes (7.63%) required ICL explantation, phacoemulsification and posterior chamber IOL implantation. The incidence of clinically relevant cataract was significantly higher with the V3 model than with the V4 (P = .007).
“Cataract incidence rate depends on the ICL model implanted and is expected to drop significantly with the recent improvements in the design of intraocular lenses,” the study authors said.
Mean endothelial cell density decreased 19.75%.
Mean lens vault decreased from 444 µm 1 day after surgery to 272.4 µm at 12 years; the difference was statistically significant (P < .05).
Five cases (3.47%) of retinal detachment were reported, and all were treated successfully with pars plana vitrectomy.
Moya would like to continue to study safety and efficacy outcomes of the latest ICL model over the long term.
“It would be interesting doing a revision of security and refractive stability in the longer term, as well as confirming the low incidence of severe complications,” he said. – by Kristie L. Kahl and Matt Hasson
- Reference:
- Moya T, et al. J Refract Surg. 2015;doi:10.3928/1081597X-20150727-05.
- For more information:
- Tomás Moya, MD, PhD, can be reached at Gran Vía del Marqués del Turia, 9, 46005 Valencia, Spain; email: moyacalleja@hotmail.com.
Disclosure: Moya reports no relevant financial disclosures.
Perspective
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Jorge L. Alió, MD, PhD
This paper highlights what is already known in phakic IOLs: Their predictability and refractive stability are excellent. Vision is enhanced due to magnification in parallel to the increase in the myopic correction. In this respect, all phakic IOLs are doing an identical job. The problem comes with the complications, and this paper highlights again the high rate of cataracts that develop with this particular type of lens. The incidence of 13.88% is indeed doubtfully acceptable for a refractive surgical procedure that claims to be safe. Cataract surgery in the young or middle-aged myope may lead to significant retinal complications, and what is going to be a happy refractive surgical procedure ends in a complex vitreoretinal procedure and relevant loss of sight.
This paper also highlights the advantages that have been found with the new model of this lens, the V4, such as better control of the vaulting. Further studies will confirm if the new innovations of this lens, the CentraFLOW, with a hole in the center are going to improve this remarkable complication. The endothelial cell loss, formerly reported by other authors, is low with this lens and nonprogressive. It is mainly related to the surgical performance and is one of the advantages of this model. The conclusion of this paper should be that a better surgical performance, with better control of the sizing and the postoperative vaulting and other technological advantages, might make this remarkable procedure, phakic IOL implantation, a safer technique than it has been so far.
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