Abstract

This clinical trial evaluated the ease of lenticule removal and visual outcomes for myopic refractive correction with or without astigmatism, with a new femtosecond laser (aka ELITA). A single arm, bilateral, prospective study in myopic subjects ≥18 years from 4 clinical sites. Two hundred and thirty eight (238) myopic eyes were treated at 4 sites for vision correction using the ELITA system. Main outcomes included an assessment of ease of lenticule removal following surgery, UCVA, BCVA and MRSE at different timepoints. 237, 224, 216, 162 , 128 & 122 eyes were available for analysis at 1W, 1,3,6,9 & 12 M post op. 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 3M 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. These results demonstrate excellent visual outcomes with the new ELITA laser.