Evaluation Ease Of Lenticule Removal And Visual Outcomes After A Lenticule Procedure With Elita Femtosecond Laser System
Published 2023
- 41st Congress of the ESCRS
Reference: FP07.05
| Type: Free paper
| DOI:
10.82333/1pxy-2x15
Authors:
Mahipal Sachdev* 1
, Rohit Shetty 2
, Brian Schwam 3
, Pooja Khamar 2
, Ritika Sachdev 1
, Raghav Malik 1
, Michal Laron 4
, Andrew Voorhees 4
, Hong Fu 4
, Ying Wang 4
, Alejandra Gonzalez Calle 4
, Priya Janakiraman 4
, Luis Vargas 4
1Centre For Sight,New Delhi,India, 2Narayan Nethralaya,Bengaluru,India, 3JJSV,Jacksonville,United States, 4JJSV,Milpitas,United States
Purpose
Johnson & Johnson Surgical Vision has developed the ELITA femtosecond laser system. This clinical trial evaluated the ease of lenticule removal and visual outcomes for myopic refractive correction with or without astigmatism up to 12-months post-operatively.
Setting
This clinical trial is part of a new femtosecond laser development project (ELITA) and is performed at 2 clinical sites in India. This is a single arm, bilateral prospective treatment study involving subjects 18 years or older with myopia with or without astigmatism.
Methods
A single arm, bilateral, prospective study in myopic subjects ≥18 years from 2 clinical sites. One hundred and seventy (170) myopic eyes were treated at 2 sites for vision correction using the ELITA system. Mean pre-op MRSE was -4.14 D (Range: -8.88 D to -1.38 D; SD: 1.32 D). 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 months postoperatively.
Results
158 eyes were available for analysis at 1 week post-op, 130 at 1 month, 138 at 3 months, 124 at 6 months, 124 at 9 months and 16 eyes at 12 months post op. For lenticule removal, surgeons reported a favorable response of no/mild dissection required in 85% of eyes, moderate dissection in 13% of eyes, and significant dissection in 1.8% of eyes. UCVA of 20/20 or better was achieved in 85%, 91%, 96%, 96%, 95% and 100% of eyes at 1 week and 1, 3, 6, 9, and 12-months post-op, respectively. MRSE within ±0.50 D was achieved in 89%, 89%, 94%, 91%, 90% and 94% of eyes at the same visits, respectively. BSCVA of 20/20 or better was achieved in 100% of eyes starting from the 3-month post –op visit.
Conclusions
These results demonstrate excellent results in terms of ease of lenticule removal and visual outcomes with the new ELITA femtosecond laser system.