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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hôpital Fondation A. de Rothschuld
RECRUITING
Paris
Contact Information
Primary
Amélie YAVCHITZ, MD
ayavchitz@for.paris
01 48 03 64 54
Backup
Alain SAAD
asaad@for.paris
Time Frame
Start Date: 2022-02-09
Estimated Completion Date: 2027-02
Participants
Target number of participants: 71
Treatments
Experimental: TransPRK
Active_comparator: Alcohol PRK
Related Therapeutic Areas
Sponsors
Leads: Fondation Ophtalmologique Adolphe de Rothschild

This content was sourced from clinicaltrials.gov

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