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

Fondation Ophtalmologique Adolphe de Rothschild

Status: Terminated

Conditions: Myopia; Astigmatism

Treatments: Procedure: Alcohol PRK; Procedure: TransPRK

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05072977

ASD_2021_8

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

71 participants in 2 patient groups

TransPRK

Experimental group

Treatment:

Procedure: TransPRK

Alcohol PRK

Active Comparator group

Treatment:

Procedure: Alcohol PRK