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Safety and Efficacy of a New Transepithelial Photorefractive Keratectomy Treatment
This is a prospective, comparative, randomized, controlled, single-blind, single-surgeon, single-center PMCF clinical study whereby participants undergoing refractive surgery for correction of ametropia will receive a transepithelial PRK (tPRK) and conventional PRK treatment in the contralateral eye. To avoid bias in the clinical outcomes, the two PRK treatment options are randomized to the eyes of the patients based on ocular dominance. In addition, a 1:1 randomization is applied within the tPRK group to eyes with and without end-treatment laser polishing. Both procedures, standard PRK and tPRK, are performed in a one-step procedure. The main difference between the procedures is, that in conventional PRK, the epithelium will be removed using alcohol, whereas in tPRK procedures, the epithelium will be removed by laser ablation.
Details
| Lead sponsor | Bausch & Lomb Incorporated |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 39 |
| Start date | Tue Feb 02 2021 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Mon Mar 21 2022 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Ametropia
Interventions
- Transepithelial Photorefractive keratectomy (tPRK) without laser polishing
- Transepithelial Photorefractive keratectomy (tPRK) with laser polishing
- Standard Photorefractive keratectomy (PRK)
Countries
Philippines