gms | German Medical Science

Purpose: To share study results, for the first time in Europe, from a 17-site U.S. clinical trial of a light adjustable intraocular lens that can be optimized postoperatively using ultraviolent (UV) light. Results, including uncorrected and corrected visual acuity achieved, safety measures, and accuracy to target refraction, will also be compared to European experience of the light adjustable technology.

Methods: All U.S. RxLAL participants (n=391) 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. Six months post-implantation, patients returned to analyze outcomes. This evaluation also compares results to published European experience (n=122) in a similar cohort.

Results: At 6 months postop., 30% of RxLAL eyes (118/391) achieved 20/16 or better UCVA, 70% (274/391) achieved 20/20 or better, and 92% (358/391) achieved 20/25 or better. 91.8% of U.S. study eyes (358/391) had an achieved correction within 0.50 D of the attempted MRSE correction and 100% of eyes (391/391) met 20/40 or better BCVA safety criteria. A published European study showed similar results with 25% of RxLAL patients (31/122) achieving 20/16 or better UCVA, 88% (107/122) achieving 20/20 or better, and 100% (122/122) achieving 20/25 or better. In the European cohort, the percentage of eyes within 0.50D of target correction was even higher (98% or 119/122).

Conclusion: 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. This new level of refractive precision may also improve binocular vision techniques such as monovision; further investigations will be needed to confirm this.