Safety and Efficacy of a New Transepithelial Photorefractive Keratectomy Treatment - Trial NCT04698174
Access comprehensive clinical trial information for NCT04698174 through Pure Global AI's free database. This phase not specified trial is sponsored by Bausch & Lomb Incorporated and is currently Recruiting. The study focuses on Ametropia. Target enrollment is 33 participants.
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Study Focus
Transepithelial Photorefractive keratectomy (tPRK) without laser polishing
Interventional
procedure
Sponsor & Location
Bausch & Lomb Incorporated
Timeline & Enrollment
N/A
Feb 02, 2021
Apr 01, 2022
Primary Outcome
Absolute refractive predictability
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT04698174
Non-Device Trial