Comparing two methods of corneal epithelial removal in eye surgery
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
This study tests whether using a laser or alcohol to remove the outer layer of the cornea during eye surgery leads to less haze for people with nearsightedness and astigmatism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 71 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Locations | 1 site (Paris) |
| Trial ID | NCT05072977 on ClinicalTrials.gov |
What this trial studies
This study compares the occurrence of corneal haze in patients undergoing Photorefractive Keratectomy (PRK) using two different methods of epithelial removal: TransPRK, which uses laser ablation, and Alcohol PRK, which involves mechanical debridement with alcohol. The study aims to quantitatively measure corneal haze using patented optical coherence tomography (OCT) software to determine if TransPRK results in less haze compared to Alcohol PRK. By evaluating these two approaches, the study seeks to improve outcomes for patients with myopia and astigmatism undergoing refractive surgery.
Who should consider this trial
Good fit: Ideal candidates are individuals with simple myopia or myopic astigmatism planning to undergo PRK in both eyes.
Not a fit: Patients with contraindications to refractive surgery or those with a history of corneal surgery or ocular pathology other than myopia or astigmatism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing PRK.
How similar studies have performed: While the approach of using TransPRK is relatively novel, previous studies have indicated potential benefits of laser-based epithelial removal methods in reducing complications associated with PRK.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Paris
- Hôpital Fondation A. de Rothschuld — Paris, France (Recruiting)
Study contacts
- Principal investigator: Alain SAAD, MD — Hôpital Fondation A. de Rothschild
- Study coordinator: Amélie YAVCHITZ, MD
- Email: ayavchitz@for.paris
- Phone: 01 48 03 64 54
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.