Evaluation Ease Of Lenticule Removal And Visual Outcomes After A Lenticule Procedure With Elita Femtosecond Laser System
Published 2024 - 42nd Congress of the ESCRS
Reference: FP20.09 | Type: Free paper | DOI: 10.82333/dk03-j627
Authors: Rohit Shetty* 1 , Mahipal Sachdev 2 , Pooja Khamar 1 , Raghav Malik 2 , Brian Schwam 3 , Michal Laron 4 , Andrew Voorhees 4 , Hong Fu 5 , Ying Wang 4 , Alejandra Gonzalez Calle 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, 5Johnson and Johnson,Milpitas,India
Purpose
Johnson & Johnson Surgical Vision has developed a new femtosecond laser (aka ELITA). This clinical trial evaluated the ease of lenticule removal and visual outcomes for myopic refractive correction with or without astigmatism are available up to 12-months post-operatively.
Setting
A single arm, bilateral, prospective study in myopic subjects ≥18 years from 4 clinical sites was reported in this study
Methods
Two hundred and thirty eight (238) myopic eyes were treated at 4 sites (2 in India, 1 in Singapore and one in Croatia) for vision correction using the ELITA system. Main outcomes included an assessment of ease of lenticule removal following surgery, uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA) and manifest refraction spherical equivalent (MRSE) at different timepoints up to 12 month postoperative visit.
Results
237 eyes were available for analysis at 1-week post-op, 224 at 1-month, 216 at 3-months, 162 at 6 months, 128 at 9 months and 122 at 12 months post op. Surgeons reported 85% favorable response (no/mild dissection) on lenticule removal, 15% as moderate and 1 % as significant dissection needed. UCVA of 20/20 or better was achieved in 78%, 85%, 93%, 94%, 95% and 97% of eyes at 1W and 1,3,6, 9 and 12 MO post-op. BCVA of 20/20 or better was achieved in 99.5% of eyes after the 3 month follow up post op. MRSE within ±0.50 D was achieved in 82%, 85%, 91%, 91%, 88% and 89% of eyes at the same visits.
Conclusions
These results demonstrate the ease of lenticule removal and excellent visual outcomes with the new ELITA femtosecond laser.