Prospective Single-Center Trial to Evaluate Safety and Efficacy of Creating LASIK Flaps With Femtosecond Laser
Narrative Responses:
Purpose
To evaluate the performance of a femtosecond laser (LenSx, Alcon) in creating corneal LASIK flaps using standard outcome measures.
Methods
This is a prospective, single-center clinical trial of 110 eyes of 59 subjects undergoing LASIK surgery requiring an initial corneal flap. Intraoperative assessment of flap thickness measurement was done. Postoperatively, uncorrected and best-corrected distance visual acuity, manifest refraction, IOP, and slit-lamp examination at one day, one week and one month were measured.
Results
The mean achieved flap thickness in the 2 mm center zone was 117 ± 12.3 μm. 94% of cases achieved 20/40 or better one month postoperatively. The mean one month postoperative SEQ was -0.21 D ± 0.46 (range: -2.00 to 0.50 D). The mean and standard deviation of IOP at one month postop was 13.99 ± 3.26 mmHg.
Conclusion
The femtosecond laser and the patient interface demonstrated excellent performance and clinical results for flap creation in 110 consecutive eyes. High levels of flap thickness accuracy and reproducibility were also consistent with published reports with other femtosecond laser platforms.