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Evaluation of visual acuity and refractive accuracy from European and US clinical trials of an intraocular lens that can be non-invasively adjusted after implantation

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Session Details

Session Title: Presented Poster Session: Cataract Surgery Outcomes

Venue: Poster Village: Pod 1

First Author: : I.Conrad-Hengerer GERMANY

Co Author(s): :    F. Hengerer   B. Dick   J. Doane        

Abstract Details

Purpose:

To compare results between European and US studies examining the visual acuity and refractive accuracy of a light adjustable intraocular lens that can be optimized postoperatively using ultraviolet (UV) radiation. Uncorrected visual and best corrected visual acuity achieved, as well as accuracy to target refraction was measured for all patients.

Setting:

European study (n=122 eyes) was performed at Ruhr University Eye Hospital, Bochum, Germany, and the U.S. study (n=391 eyes) was performed at 17 sites. Setting included both hospital and private practices. All patients had visually significant cataract and volunteered for the trial. All sites received ethics committee approvals.

Methods:

This evaluation compares refractive accuracy outcomes from two prospective studies. All participants underwent small incision phacoemulsification followed by implantation of a foldable, 3-piece light adjustable lens. After post-op wound healing and refraction stabilization (~2 weeks) all eyes were treated with UV light in a pre-determined pattern to induce a targeted spherical and cylindrical refractive change. Once the desired correction was achieved, the light adjustable lens was treated again to lock in the outcome. At six-months post-implantation, patients returned to determine the achieved uncorrected and corrected visual acuities and refractive corrections.

Results:

: At 6 months postoperative, 25% of European study eyes (31/122) achieved 20/16 or better, 88% (107/122) achieved 20/20 or better, and 100% (122/122) achieved 20/25 or better. In the US study, 30% of eyes (118/191) achieved 20/16 or better, 70% (274/391) achieved 20/20 or better, and 92% (358/391) achieved 20/25 or better. 100 percent of EU (n=122) and US (n=391) eyes met 20/40 or better BCVA safety criteria. At 6 months postoperative, 91.8% of US eyes (358/391) had an achieved correction within 0.50 D of the attempted MRSE correction, and this was higher in EU population (98% or 119/122).

Conclusions:

Cataract surgery is one of the most successful procedures in medicine; however, residual refractive error is still common due to variations in post-operative lens position and wound healing. By adding the ability to adjust the lens after surgery, the light adjustable lens overcomes the prediction limitations associated with cataract surgery. LASIK-like refractive precision was demonstrated in this analysis (92%-98% within 0.50D) and > 2x improvement in 20/20 over non-adjustable IOLs (70%-88% with LALs versus ~38%. This new level of refractive precision may also improve binocular vision techniques such as monovision; further investigations will be needed to confirm this.

Financial Disclosure:

NONE

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