Preliminary U.S. Clinical Trial Results: New Femtosecond Laser Lenticule Extraction Procedure for Spherical Myopia Correction

Doane, John

Preliminary U.S. Clinical Trial Results: New Femtosecond Laser Lenticule Extraction Procedure for Spherical Myopia Correction

Monday, April 28, 2014: 8:06 AM

Room 151A (Boston Convention and Exhibition Center)

John F. Doane, MD, Discover Vision Centers, Leawood, Kansas, USA

William W. Culbertson IV, MD, Bascom Palmer, Miami, FL, USA

Jon G. Dishler, MD, Dishler Laser Institute, Greenwood Village, CO, USA

Vance M. Thompson, MD, Vance Thompson Vision, Sioux Falls, SD, USA

John A. Vukich, MD, Davis Duehr Dean, Madison, Wisconsin, USA

Sonia H. Yoo, MD, Bascom Palmer Eye Institute, Miami, FL, USA

Narrative Responses:

Purpose
Present preliminary data from an FDA approved clinical trial to evaluate the safety and effectiveness of a femtosecond laser lenticule removal procedure for the reduction or elimination of spherical myopia from ≥ -1.00 D to ≤ -8.00 D with MRSE ≤ -8.25 D.

Methods
In this prospective multi-center clinical trial, subjects 22 years and older are treated for spherical myopia and followed over a 12-month period. The investigative procedure uses the VisuMax Femtosecond Laser to cut a refractive corneal lenticule, after which the lenticule is removed through a small side incision. Effectiveness, stability, and safety parameters are evaluated in accordance with the ANSI standard on Laser Systems for Corneal Reshaping. Preoperative and postoperative clinical assessments include manifest/cycloplegic refraction, UCVA and BSCVA, slit-lamp exam, fundus exam, topography, pachymetry, mesopic pupil size, wavefront analysis, mesopic contrast sensitivity, IOP, and patient satisfaction questionnaire.

Results
Results are available from 103 subjects with follow-up from Day 1 - 12-Month postoperatively. Mean age was 35 years, with 62 females/41 males. At 3, 6, and 9-month visits, 95% (91/96), 94% (74/79), and 98% (46/47) of eyes were within ± 0.50 D of intended and 91% (88/97), 95% (76/80), and 91% (43/47) had 20/20 or better UCVA. Mean preoperative MRSPH was -4.48 D ± 1.78 D; postoperative MRSPH at 3, 6, and 9 months was 0.01 D ± 0.25 D, 0.02 D ± 0.37 D, and 0.03 D ± 0.20 D. No eyes lost ≥ 2 lines BSVCA beyond the 7-day visit. Operative events included 2 suction losses, 1 radial cap tear and 1 case of partial lenticule removal. Visual outcomes were excellent; subject satisfaction is high.

Conclusion
Results are promising from this study of a femtosecond laser refractive lenticule extraction procedure for the correction of myopia. Data from the first 103 eyes treated in the study shows a positive safety and effectiveness profile. FDA has granted approval to continue enrollment up to 360 subjects.