Flap Thickness And Visual Outcomes Comparison Between The Elita Femtosecond Laser System And Ifs
Published 2023 - 41st Congress of the ESCRS
Reference: PP03.12 | Type: Free paper | DOI: 10.82333/bf31-tt36
Authors: Ritika Sachdev 1 , Mahipal Sachdev* 1 , Rohit Shetty 2 , Brian Schwam 3 , Pooja Khamar 2 , Raghav Malik 1 , Michal Laron 4 , Andrew Voorhees 4 , Hong Fu 4 , Ying Wang 5 , Alejandra Gonzalez Calle 4 , Priya Janakiraman 4 , Luis Vargas 4
1Centre For Sight,Delhi,India, 2Narayan Nethralaya,Bengaluru,India, 3JJSV,Jacksonville,United States, 4JJSV,Milpitas,United States, 5Centre For Sight,Milpitas,United States
Purpose
Johnson & Johnson Surgical Vision has developed the ELITA femtosecond Laser System (ELITA). In this clinical trial the flap thickness accuracy for Laser In-situ Keratomileusis (LASIK) was evaluated with ELITA compared to iFS in terms of intended versus achieved thickness and visual outcomes up to 1-month post-operatively.
Setting
This clinical trial is part of a new FS laser development project (ELITA) and is performed at 2 clinical sites in India. This is a randomized, single arm, contra-lateral, prospective treatment study involving subjects 18 years or older with refractive errors within LASIK treatment indications.
Methods
A clinical trial was conducted in three clinical sites where 83 consecutive subjects received LASIK surgery using the ELITA laser system in 1 eye and iFS in the fellow eye for flap creation. Flap thickness was targeted at 110 µm and calculated as the average of three measurements from three AS-OCT scans. Uncorrected visual acuity (UCVA), manifest refraction spherical equivalent (MRSE), and best spectacle-corrected visual acuity (BSCVA) were obtained at 1 month postoperatively.
Results
Results from 83 patients were available for analysis at 1-day post-op and 64 at 1 month post-op. Flap thickness was targeted at 110 µm. The Mean flap thickness at 1-mo for the ELITA laser system was 108.3 (SD ±4.3µm), and 108.5 (SD ±3.5 µm) for iFS, achieving an accurate flap thickness with both ELITA and iFS. Mean pre-op MRSE was -4.14±1.98D (ELITA) and -4.15±1.90D (iFS). 97% of ELITA eyes and 94% of iFS eyes had MRSE within +/- 0.50D from emmetropia at 1- month post-op. UCVA was 20/20 or better in 94% of ELITA eyes and 88% of iFS eyes at 1-day post-op, and 98% of ELITA eyes and 95% of iFS eyes at 1 month post-op. BSCVA was 20/20 or better in 100% of both ELITA eyes and iFS eyes at 1 month post op.
Conclusions
The ELITA femtosecond laser system demonstrates accurate flap thickness, similar to iFS, with comparable variability and excellent visual outcomes when creating flaps for LASIK.