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

NCT05072977 | Terminated

• 1 other identifier: ASD_2021_8
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myopia; Astigmatism

Keywords

Myopia; Astigmatism; Corneal haze; Trans Photorefractive Keratectomy; Alcohol Photorefractive Keratectomy

Outcome Measures

Primary Outcomes (1)

• Corneal haze assessed with the the software analysing the corneal OCT images

  Corneal haze assessed by the intensity of the luminosity of the whole cornea (expressed as a percentage) evaluated by the software analysing the corneal OCT images.

  1 month after refractive surgery

Study Arms (2)

TransPRK

EXPERIMENTAL

Procedure: TransPRK

Alcohol PRK

ACTIVE COMPARATOR

Procedure: Alcohol PRK

Interventions

TransPRK PROCEDURE

A Merocel sponge is soaked in a saline solution to expand before being gently applied to the corneal surface in three gestures similar to painting. This standardised procedure avoids inhomogeneous wetting of the cornea, which would result in uneven ablation. The laser ablation is then performed.

TransPRK

Alcohol PRK PROCEDURE

A ring is placed in the centre of the cornea and filled with 20% alcohol. After 20 seconds of exposure, the alcohol is absorbed with a small sponge and the corneal epithelium is debrided with a polyvinyl alcohol expanding sponge (Merocel, Medtronic). The entire cornea is rinsed with balanced salt solution and the epithelium is peeled away from the corneal stroma. The corneal bed is then dried with a small sponge and laser ablation is performed.

Alcohol PRK

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Only one eye operated on
• At least one contraindication to refractive surgery, namely : keratoconus, minimum corneal 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hôpital Fondation A. de Rothschuld

Paris, 75019, France

Location

MeSH Terms

Conditions

Myopia; Astigmatism; Corneal Opacity

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Corneal Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Alain SAAD, MD

  Hôpital Fondation A. de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 11, 2021
• Study Start: February 9, 2022
• Primary Completion: June 5, 2023
• Study Completion: July 10, 2024
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

FR (1)