Topography-guided vs. Wavefront Optimized Corneal Refractive Surgery: A Prospective Contralateral Randomized Double-masked Study

What this Trial Is About

Researchers are comparing two laser ablation profiles, wave-front optimized (WFO) and topography-guided (TG) Contoura Vision, to determine which provides better visual outcomes during refractive eye surgeries like Photorefractive keratectomy (PRK) or Laser-assisted in situ Keratomileusis (LASIK). This study is a prospective randomized contralateral double-masked trial involving adult patients aged 21 to 50 years who qualify for PRK or LASIK. The study aims to evaluate differences in post-operative refractive error and visual acuity between these two ablation profiles. Each participant will undergo either PRK or LASIK surgery, with one eye treated using the WFO ablation profile and the other eye treated with the TG Contoura Vision profile. The choice between PRK and LASIK is made by the surgeon based on patient preference and clinical suitability. The TG profile requires additional pre-operative preparation using the VARIO Topolyzer device, which collects detailed corneal shape data. Patients are randomized to receive WFO in one eye and TG in the other, and the study team and patients are masked accordingly during follow-up. Participants will have standard pre- and post-operative evaluations including vision assessments, contrast sensitivity, keratometry, and axial length measurements. Post-operative follow-ups occur on day 1, week 1, and months 1, 3, and 6, during which visual acuity and refractive errors are measured. A symptoms questionnaire (PROWL) specific to eye surgery will be completed before and after surgery. All collected data will help compare the visual outcomes and safety profiles of the two ablation methods over six months.

CONTOURA vs WFO Ablation PRK & LASIK