Impact of Donor Lenticule Depth on the Outcome of Allogeneic Corneal Inlay Treatment for Presbyopia

Abstract

Purpose: The aim of this study was to assess the impact of the lenticule’s position within the donor cornea on visual, refractive, and topographic outcomes in patients who undergo allogeneic corneal inlay (Allotex Inc., Boston, MA) implantation.

Methods: This retrospective data analysis included 86 patients at 5 study sites that were part of the Allotex EU multicenter clinical trial. During the study, an allogeneic corneal inlay was implanted in the nondominant eye of emmetropic patients with presbyopia. Uncorrected distance visual acuity, uncorrected intermediate visual acuity, uncorrected near visual acuity, corrected distance visual acuity, distance-corrected near visual acuity, refraction, and keratometric measurements were assessed preoperatively and at 6 months postoperatively. Correlation between the depth of the cornea from which the donor lenticule was obtained and these parameters was investigated. In addition, 3 subgroups, based on the depth of the donor lenticule (anterior, middle, and posterior), were compared.

Results: Uncorrected intermediate visual acuity, uncorrected near visual acuity, and distance-corrected near visual acuity increased while uncorrected distance visual acuity, corrected distance visual acuity, and keratometric values decreased 6 months postoperatively (P , 0.05). No correlation was found between the clinical parameters and lenticule depth. In the subgroup analysis based on lenticule depth, there was no significant difference between the groups in the change in any parameter (P . 0.05).

Conclusions: Lenticules obtained from different depths can be used as corneal inlays, allowing multiple patients to benefit from one donor cornea.