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Photorefractive Keratectomy (PRK) : Comparison of Corneal Haze Between Two Modes of De-epithelialisation (Laser Versus Manual Alcohol) — H-TransPKR  

Myopia Clinical Trial

Official title:
Prospective Randomised Controlled Study in 2 Parallel Arms Comparing Corneal Haze, Visual and Refractive Outcomes and Postoperative Pain According to the Mode of De-epithelialisation (Laser Versus Manual Alcohol) During Photorefractive Keratectomy

Clinical Trial Summary

surgical correction of ametropia. A number of improvements have been introduced to overcome the side effects and complications such as corneal haze, epithelial irregularities induced by wound healing, pain and delayed visual acuity recovery associated with PRK surgery. During traditional PRK, the corneal epithelium is mechanically debrided before stromal ablation is performed. Alcohol PRK is frequently used as an alternative to mechanical epithelial debridement and is considered simpler and faster. Transepithelial PRK (TransPRK) is a new method in which the corneal epithelium is photoablated by the laser in one step using a specific ablation profile. This study attempts to establish a means of quantitatively and objectively measuring corneal haze, using patented software based on optical coherence tomography (OCT) of the cornea. This will confirm or refute the hypothesis of a lower occurrence of corneal haze after TransPRK (experimental group) versus PRK with alcohol (control group). Each patient will have one eye randomised to one of the two groups being compared.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05072977
Study type Interventional
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact Amélie YAVCHITZ, MD
Phone 01 48 03 64 54
Email ayavchitz@for.paris
Status Recruiting
Phase N/A
Start date February 9, 2022
Completion date August 2025
View Details
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