Actual and theoretical risks for visual loss following use of the implantable contact lens for moderate to high myopia

PURPOSE: To estimate the actual and theoretical risks for visual loss associated with use of the implantable contact lens (ICL). SETTING: Multicenter clinical trial data. METHODS: An established model for estimating the risk for visual loss associated with retinal detachment (RD) following clear lens extraction (CLE) was modified to be applicable to the ICL. The risk for developing RD and the outcomes of RD surgery based on current lens extraction and RD repair techniques were updated. Non-RD-related risks for pseudophakia based on United States Food and Drug Administration (FDA) guidelines, actual visual loss data from the FDA ICL study, and calculated risks assuming a large future risk (10 times the current risk) of cataract development were also added. RESULTS: The additional risk for visual loss due to cataract surgery is estimated at 0.19% and for subsequent RD assuming 10 times the current rate of cataract is 0.37%. Using an ultraconservative (high) model and adding the actual loss observed with the ICL, the total risk is 1.39%. The risk increases by 0.5% to 0.6% with each 10% increase in cataract incidence (eg, 10% to 20%, 20% to 30%). The risk for visual loss with CLE and/or laser in situ keratomileusis/photorefractive keratectomy in the same range of myopia is possibly 3.0% to 6.5%. CONCLUSIONS: The ICL represents a viable alternative to currently available refractive procedures based on an analysis of the risk for visual loss.