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Safety and Efficacy of a New Transepithelial Photorefractive Keratectomy Treatment

NCT04698174 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2022-10-07

No results posted yet for this study

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.

Conditions

  • Ametropia

Interventions

PROCEDURE

Transepithelial Photorefractive keratectomy (tPRK) without laser polishing

Transepithelial Photorefractive keratectomy (tPRK) with laser ablation of the corneal epithelium and stroma in a single-step procedure using the B+L Teneo 317 Model 2 Excimer Laser.

PROCEDURE

Transepithelial Photorefractive keratectomy (tPRK) with laser polishing

Transepithelial Photorefractive keratectomy (tPRK) using the B+L Teneo 317 Model 2 Excimer Laser with end-treatment laser polishing using a fixed thickness of the additional layer of 5 μm.

PROCEDURE

Standard Photorefractive keratectomy (PRK)

Conventional Photorefractive keratectomy (PRK) with alcohol-assisted epithelium ablation. Then the aspheric ablation profile will be performed using the B+L Teneo 317 Model 2 Excimer Laser.

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Robert Ang, MD · Asian Eye Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-02
Primary Completion
2022-03-21
Completion
2022-03-21

Countries

  • Philippines

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04698174 on ClinicalTrials.gov