Informations générales (source: ClinicalTrials.gov)

NCT05072977 En recrutement IDF
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 (H-TransPKR)
Interventional
  • Astigmatisme
  • Opacité cornéenne
  • Myopie
N/A
Fondation Ophtalmologique Adolphe de Rothschild (Voir sur ClinicalTrials)
février 2022
février 2027
23 mai 2025
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.
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Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
HOPITAL FONDATION A. DE ROTHSCHILD Alain SAAD En recrutement IDF 21/06/2024 13:33:57  Contacter
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Hôpital Fondation A. de Rothschuld - 75019 - Paris - France Alain SAAD, MD En recrutement Contact (sur clinicalTrials)

Critères

Tous
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


- 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