Through-focus performance with a corneal shape-changing inlay: One-year results.

PURPOSE: To evaluate improvement in the through-focus acuity and visual function provided by a corneal inlay designed to modify the surface shape of the central cornea.

SETTING

Two clinical practices, United States.

DESIGN

Prospective nonrandomized clinical trial.

METHODS

Emmetropic patients with presbyopia who required a reading addition (add) from +1.50 to +2.00 diopters (D) had implantation of the Raindrop Near Vision Inlay in the nondominant eye. The inlay was designed to modify the anterior curvature of the central cornea with the intent to improve near and intermediate vision. At the preoperative and 1-year postoperative visits, the following visual functions were recorded: defocus curves in the nondominant eye, required add for best near vision, distance-corrected binocular contrast sensitivity, and uncorrected and corrected visual acuity at 6 m, 80 cm, and 40 cm.

RESULTS

The study comprised 30 patients. One year postoperatively, on average, distance-corrected near acuity improved by more than 3 lines, with patients achieving a distance-corrected acuity of 0.3 logMAR (20/40) or better across a 3.50 D range of defocus. Binocular uncorrected visual acuity of 0.2 logMAR (20/32) or better at distance, intermediate, and near distances was obtained in 97% of patients. The mean reduction in the reading add was 1.60 D. There was no significant change in binocular contrast sensitivity. Overall patient satisfaction was high.

CONCLUSION

A corneal inlay in the nondominant eye of emmetropic patients provided a significant increase in the range of functional vision at intermediate and near, with no loss in binocular distance acuity.

FINANCIAL DISCLOSURE: Drs. Whitman, Hovanesian, Steinert, and Koch received compensation for participating in the study from Revision Optics, Inc. Drs. Steinert and Koch are medical monitors for Revision Optics, Inc. None of the other authors has a financial or proprietary interest in any material or method mentioned.