Clinical Investigation of the WaveLight® UV Femtosecond Laser Lenticle Extraction Sphere Nomogram

Summary:

The WaveLight® Ultraviolet Femtosecond Laser System, Model 1026 (UV fs-Laser) with accompanying Patient Interface, Model 1507 has been developed to provide an alternative refractive surgery option that uses UV light with a wavelength of 347 nm instead of IR light. The UV-Femtosecond Laser Assisted Lenticular Extraction procedure creates canals in the cornea and an intrastromal lenticule which, when removed, provides the refractive error correction.

This is an interventional, prospective, single-arm, single-eye, unmasked, multi-center clinical study. This study uses a femtosecond laser with UV radiation. The UV fs-Laser has been used in human subjects in three studies: one first-in-human early feasibility study has been completed, another feasibility study for the UV fs-Laser lenticule extraction procedure is ongoing, and another refractive procedure study using the UV fs-Laser to create a corneal flap for LASIK is also ongoing. The goal of this trial is to collect data on the safety and effectiveness of the sphere nomogram component of the UV fs-Laser when using the lenticule extraction procedure in a patient population that is distributed across three sphere diopter treatment groups.

Brief Summary after completion:

37 subjects were enrolled, of whom 31 were exposed to the test device, and 30 completed the study

Subjects in this study had an overall mean age of 26.7 years, with 36.7% female subjects in the study as compared to 63.3% male subjects. Subjects self-identified predominantly as Asian and Not Hispanic or Latino.

Primary Effectiveness: The mean spherical manifest refraction at Screening was -4.158 D. The mean spherical manifest refraction measurements improved as early as Week 1 postoperative (-0.683 D) and remained stable at all postoperative visits, including Month 6 postoperative (-0.707 D).

Primary Safety: The mean BCDVA at Screening was -0.047 logMAR. The mean BCDVA was similar at all postoperative visits, including Month 6 postoperative (-0.015 logMAR). The percentage for change in BCDVA was reported as > 2 lines worse in 1 subject at Week 1 (3.2%), Month 3 (3.2%), and Month 6 (3.3%) postoperative.

Ocular SAEs for study eyes were reported in 3 subjects (9.7%). There were 4 total events reported (1 each) of corneal endothelial cell loss greater than 10% from preoperative (1, 3.2%), corneal infiltrates (1, 3.2%), corneal opacity (1, 3.2%), and ocular procedural complication (1, 3.2%).

Overall, the treatment and accuracy of the sphere lenticule nomogram (treatment calculation algorithm) of the UV fs-Laser across the allowed dioptric range in subjects with no or low cylinder were safe. The overall results showed that the UV fs-Laser reduced spherical refractive error. However, the results of this study warrant further investigation into methods for reducing variability in treatment outcomes, particularly for higher dioptric treatments.