One-year safety and efficacy results of a hydrogel inlay to improve near vision in patients with emmetropic presbyopia.

PURPOSE: To conduct a feasibility study of the safety and efficacy of a corneal contouring inlay as a treatment for emmetropic presbyopia.

METHODS

The Raindrop corneal inlay (ReVision Optics, Inc., Lake Forest, CA) was implanted on the corneal stromal bed beneath a keratotomy flap in 20 nondominant eyes of 20 patients. The implant is designed to cause a change in the curvature of the overlying cornea, with a subsequent multifocal change in refractive power. Efficacy outcome was defined as at least 75% of eyes with uncorrected near visual acuity of 0.3 logMAR (20/40 Snellen) or better at 6 months. Main safety outcomes were retention of preoperative best-corrected distance visual acuity and reports of adverse events. Other outcome measures included contrast sensitivity; near, intermediate, and distance visual acuities; patient satisfaction; spectacle use; and complications.

RESULTS

All implanted eyes achieved uncorrected near visual acuity of 0.3 logMAR (20/40 Snellen) or better by the 1-week postoperative examination and remained so throughout the 1-year follow-up period, also averaging less than 0.1 logMAR (20/25 Snellen) monocularly and binocularly throughout that period. Mean binocular uncorrected distance visual acuity remained within 0.02 logMAR of the preoperative mean throughout the study. One patient who was dissatisfied with the resulting vision underwent explantation. At 1 year, 16 of 19 patients seldom or never wore glasses and all 19 were satisfied or very satisfied with their overall vision.

CONCLUSIONS

The hydrogel corneal inlay improved uncorrected near and intermediate visual acuity in patients with emmetropic presbyopia, with high patient satisfaction and little effect on distance visual acuity.