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Safety and Efficacy of a New Transepithelial Photorefractive Keratectomy Treatment

Ametropia Clinical Trial

Official title:
Prospective Clinical Study to Evaluate the Safety and Efficacy of a New Transepithelial Photorefractive Keratectomy Treatment

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04698174
Study type Interventional
Source Bausch & Lomb Incorporated
Contact
Status Completed
Phase N/A
Start date February 2, 2021
Completion date March 21, 2022
View Details
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