An interventional study of TransPRK and Alcohol PRK in Myopia and Astigmatism, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Not applicable, Interventional, and Treatment
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.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's enrollment of 71 is close to the median of 78 across 923 interventional studies indexed under Myopia.
Browse Myopia studies →Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 316 studies on the registry; 78 are open to participants now.
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Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Procedure: TransPRK
Procedure: Alcohol PRK
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.
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.
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.
Time frame: 1 month after refractive surgery
This study is terminated, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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