Safety and Efficacy of a New Transepithelial Photorefractive Keratectomy Treatment
- Disease/Condition
- Ametropia
- Drug/Device/Intervention
- Transepithelial Photorefractive keratectomy (tPRK) without laser polishing
- Study type
- Interventional
- Intervention type
- procedure
- Primary sponsor
- Bausch & Lomb Incorporated
- Location
- Makati City, Philippines
- Phase
- N/A
- Start date
- Feb 02, 2021
- End date
- Apr 01, 2022
- Enrollment
- 33 participants
Absolute refractive predictability
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.
- Registry
- ClinicalTrials.gov
- Trial ID
- NCT04698174
- Type
- Non-Device Trial
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.