Long-term safety and efficacy of using a small aperture corneal inlay to treat emmetropic presbyopia

Session Details

Session Title: Intracorneal Inlays for Presbyopia

Session Date/Time: Tuesday 08/09/2015 | 16:00-18:00

Paper Time: 16:12

Venue: Main Auditorium

First Author: : J.Vukich USA

Co Author(s): :                        

Abstract Details

Purpose:

To evaluate the safety and efficacy of a small aperture corneal inlay for the treatment of naturally occurring emmetropic presbyopia over the long term.

Setting:

24 sites (US, Europe, and Asia-Pacific)

Methods:

Prospective, non-randomized clinical trial of 154 emmetropic presbyopes treated with a small aperture corneal inlay. Patients were between the ages of 45 and 60. Patient selection criteria included uncorrected near visual acuity (UCNVA) of worse than 20/40 and better than 20/100 and a best-corrected distance visual acuity (BCDVA) ≥ 20/20 in both eyes, with a cycloplegic spherical equivalent between +0.50 D and -0.75 D. The inlay was implanted monocularly in the non-dominant eye into a femtosecond laser created pocket using equivalent or less than 6X6 micron spot/line laser setting. Visual acuity and refractive stability were evaluated.

Results:

Mean UCDVA was virtually unchanged from 20/18.5 to 20/20. 92% of patients were 20/25 or better at 3-years post-op. Mean UCNVA improved 4 lines from J8 at pre-op to J2 at 3-years post-op. 53% of the patients achieved UCNVA of J2 or better and 73% were J3 or better. Mean MRSE changed from +0.02 ± 0.28D to +0.14 ± 0.72D. 96% were within ± 1.00D of intended target. No patient sustained a loss of 2 or more lines of BCDVA at 3 years.

Conclusions:

Use of a small aperture inlay for treatment of presbyopia in emmetropes improves near visual acuity while retaining good distance vision over the long-term.

Financial Interest:

One of the authors travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented