Evaluation Of Visual Outcomes After A Lenticule Removal Procedure With A New Femtosecond Laser System

Published 2022 - 40th Congress of the ESCRS

Reference: PP21.14 | Type: Free paper | DOI: 10.82333/pcjy-zc98

Authors: Rohit Shetty* ¹ , Mahipal Sachdev ² , Brian Schwam ³ , Pooja Khamar ¹ , Ritika Sachdev ² , Raghav Malik ² , Michal Laron ⁴ , Andrew Voorhees ⁴ , Hong Fu ⁴ , Ying Wang ⁴ , Luis Vargas ⁴

¹Narayana Nethralaya,Bengaluru,India, ²Centre for Sight,New Delhi,India, ³Johnson and Johnson,Jacksonville,United States, ⁴Johnson and Johnson,Milpitas,United States

Purpose

To assess early feasibility of a new femtosecond laser system for the correction of myopia and astigmatism through intrastromal lenticule removal procedure.

Setting

This clinical trial is part of a new femtosecond laser development project and is performed at 2 clinical sites in India. This is a single arm, bilateral prospective treatment study.

Methods

A prospective clinical study in myopic subjects 18 years and older was completed. Sixty-one (61) myopic subjects were treated binocularly at 2 sites for vision correction using the new femtosecond laser. Mean pre-operative MRSE was -4.16 D (Range: -2.25 D to -6.38 D; SD: 1.17 D) and mean cylinder was ‑0.62 D (SD: 0.47 D). A lenticule removal procedure in which a lenticule is created in the corneal stroma and removed through a 3 mm incision was used, and the intended correction was emmetropia for all eyes. Main outcomes measured included uncorrected and best spectacle corrected visual acuity (BSCVA), manifest refraction spherical equivalent (MRSE), and slit lamp.

Results

One hundred and fourteen (114) eyes are available for analysis at 1-week post-op, 104 at 1-month, and 104 eyes at 3-months. UCVA of 20/25 or better was achieved in 93%, 92%, and 99% of eyes at 1-week, 1-month, and 3-months post-operatively. Binocular BSCVA of 20/20 or better was achieved in 95% of eyes 1-week and 100% of eyes at 3-months post-op. MRSE within ±0.50 D was achieved in 74%, 77% and 90% of eyes at the 1-week, 1-month, and 3-months follow-up visits, respectively. MRSE within ±1.00 D was achieved in 98% of eyes at 1-week, and 99% of eyes at 3-months post-op. Corneal biomicroscopy was unremarkable in all cases at 1-day as well as 1-week post-operatively.

Conclusions

This early feasibility study demonstrates early visual recovery and accurate refractive correction resulting in the majority of subjects within 0.5D of target refraction. Further follow-up of study subjects is ongoing and will be subsequently reported.