Clinical Efficacy of the PRESBYLENS® Intracorneal Inlay for the Correction of Presbyopia

Abstract

Purpose: : Visual acuity outcomes are presented for an intracorneal inlay that provides enhanced monovision to correct presbyopia. The objective was to provide patients with bilateral distance vision and monocular near vision by creating a multi-focal visual pathway in the non-dominant eye.

Methods: : 33 emmetropic, presbyopic subjects (mean age 50 years [44 to 60], mean preop SE 0.27 D [-0.25 to 0.87], mean near add 1.9 D [1.25 to 2.5]) were implanted, under standard LASIK-style flaps, with 1.5 mm diameter hydrogel intracorneal inlays with thicknesses of less than 50 µm. Subjects were screened for tolerance to monovision and the clinical test was conducted under an IRB-approved protocol.

Results: : In the treated eye, uncorrected near visual acuity improved in over 95% of eyes. More than half of the eyes achieved 20/25 or better near visual acuity compared to 0% 20/25 or better preoperatively. Binocular uncorrected distance visual acuity did not significantly deteriorate post-operatively and all patients could read the 20/25 line. Comparison to standard monovision was made from the subjects’ preoperative defocus blur measurements. With +2 D of correction, all patients had near vision of 20/20 or better, superior to the multifocal inlay effect. However, distance vision in the treated eye would be significantly worse with monovision than the inlay, as 0% of eyes achieved 20/25 distance visual acuity with a +2 D add.

Conclusions: : This clinical test demonstrates that, in the treated eyes, significant improvement was found in uncorrected near visual acuity, with a decrease in distance visual acuity significantly less than the loss expected with a monovision treatment.

Keywords: refractive surgery: other technologies • presbyopia