NCT04698174

Safety and Efficacy of a New Transepithelial Photorefractive Keratectomy Treatment

Prospective Clinical Study to Evaluate the Safety and Efficacy of a New Transepithelial Photorefractive Keratectomy Treatment
Bausch & Lomb Incorporated·ClinicalTrials.gov·procedureRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Ametropia
Drug/Device/Intervention
Transepithelial Photorefractive keratectomy (tPRK) without laser polishing
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
Bausch & Lomb Incorporated
Location
Makati City, Philippines
Timeline & enrollment
Phase
N/A
Start date
Feb 02, 2021
End date
Apr 01, 2022
Enrollment
33 participants
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
Amblyopia ex anopsiaAmoebiasisAmoebiasis, unspecifiedMyoclonusOesophagitis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04698174
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.