Safety and Efficacy of Optimal Keratoplasty in Reduction of Hyperopia and Hyperopic Presbyopia: A Retrospective Observational Study

Abstract

Purpose To evaluate the safety and efficacy of the VIS Optimal Keratoplasty device and procedure for treating eyes with hyperopia and hyperopic presbyopia to achieve uncorrected distance visual acuity (UDVA) and uncorrected near visual acuity (UNVA) improvements. Setting Bahamas Vision Centre, Nassau, New Providence, The Bahamas. Methods 114 eyes of 57 patients with low to moderate hyperopic presbyopia (MRSE = 0.88 to 3.25 D; mean add ± standard deviation (SD) = 2.08 ± 0.43 D) received primary treatments (Txs) by the VIS NTK Optimal Keratoplasty device; 44 and 22 patients also received secondary and ternary Txs, respectively. Patients were treated to produce best UDVA and best UNVA in both eyes using a multifocal vision protocol. Safety and efficacy measures with follow-up (f/u) extending to 24 months post-Tx were analyzed. Results Safety – There were no clinically significant adverse events or complications. Efficacy – Geometric mean (gm) ± SD binocular UDVA improvements corresponded to 3.6 ± 3.9 lines gained at 1 day post-primary Tx (p < 0.01), with gradual reduction of improvement to 1.7 ± 2.1 lines gained at 24m′ post-secondary Tx. Gm binocular UNVA improvements peaked at 4.8 ± 2.9 lines gained at 1 day post-primary Tx (p < 0.01), with gradual reduction to 1.1 ± 2.6 lines gained at 24m′ post-secondary Tx. The mean durations of “functional” (>20/40) binocular UDVA and UNVA were over 2 years and ca. 6 months post-Tx, respectively. Conclusions Optimal keratoplasty appears to be safe and efficacious for improving both UDVA and UNVA in eyes with hyperopic presbyopia, The procedure is noninvasive, simple, rapid, comfortable and repeatable. UDVA improvement is long lasting (2 years or more), although UNVA improvement is temporary. Additional optimal keratoplasty Txs can be repeated whenever needed to maintain functional UNVA.