Journal of Clinical and Experimental Ophthalmology
Open Access

Abstract

Excimer Laser Shaped Allograft Corneal Inlays for Presbyopia: Initial Clinical Results of a Pilot Study

Aylin Kılıç and Burcu Nurözler Tabakcı

Purpose: To evaluate the clinical feasibility of precision shaped lenticules comprised of sterile allograft corneal tissue designed to optimize the shape of the anterior corneal surface for presbyopia correction by increasing the depth of focus and central corneal power within a prospective pilot study.

Methods: This case series included 12 eyes of 12 patients with a follow-up of 6 months. Corneal lenticules with a refractive target add power of 2.5 D (Transform, Allotex Inc. Boston, USA) is implanted in the non-dominant eyes. Manifest, and cycloplegic refraction, uncorrected distance visual acuity (UCDVA), uncorrected near visual acuity (UCNVA), best corrected distance visual acuity (BCDVA),best corrected near visual acuity (BCNVA) were measured preoperatively and 6 months postoperatively.

Results: The mean preoperative UCNVA (logMAR) in the treatment eye was 0.52 ± 0.14 and was significantly increased to 0.10 ± 0.06 (p=0.000) at the 3 month follow-up. All eyes had a UCNVA of 0.20 or better at the last follow-up visit. An expected myopic shift of the preoperative spherical equivalent refraction of +0.25 ± 0.29 D to -0.11 ± 0.28 D (p=0.017) was found. Nine out of the 12 patients reported that they were satisfied or very satisfied with the outcome of the procedure and adapted towards the blended vision generated by the increase of depth-of-focus in the non-dominant eye.

Conclusion: Preliminary results of this pilot study indicate that the sterile allograft lenticules enhance the visual performance of the patient for the near vision needs. Larger clinical studies are needed to demonstrate the effectiveness and safety with long term follow-up.