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

Last updated: December 2, 2025
Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Overall Status: Terminated

Phase

N/A

Condition

Myopia

Astigmatism

Treatment

TransPRK

Alcohol PRK

Clinical Study ID

NCT05072977
ASD_2021_8
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Planned Photorefractive Keratectomy in both eyes

  • Simple myopia or myopic astigmatism, refractive spherical equivalent between -0.50and -9.0 diopters in both eyes with regular corneal topography

Exclusion

Exclusion Criteria:

  • Only one eye operated on

  • At least one contraindication to refractive surgery, namely : keratoconus, minimumcorneal thickness < 400 µm, severe dry syndrome, progressive corneal infection

  • Personal history of corneal surgery

  • Personal history of ocular pathology other than simple myopia or myopic astigmatism

  • Pregnant or breastfeeding woman

Study Design

Total Participants: 71
Treatment Group(s): 2
Primary Treatment: TransPRK
Phase:
Study Start date:
February 09, 2022
Estimated Completion Date:
July 10, 2024

Connect with a study center

  • Hôpital Fondation A. de Rothschuld

    Paris, 75019
    France

    Site Not Available

  • Hôpital Fondation A. de Rothschuld

    Paris 2988507, 75019
    France

    Site Not Available

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