Safety and Efficacy of a New Transepithelial Photorefractive Keratectomy Treatment

Bausch + Lomb

Status: Completed

Conditions: Ametropia

Treatments: Procedure: Standard Photorefractive keratectomy (PRK); Procedure: Transepithelial Photorefractive keratectomy (tPRK) without laser polishing; Procedure: Transepithelial Photorefractive keratectomy (tPRK) with laser polishing

Study type: Interventional

Funder types: Industry

Identifiers

NCT04698174

BL1902

Details and patient eligibility

About

This is a prospective, comparative, randomized, controlled, single-blind, single-surgeon, single-center PMCF clinical study whereby participants undergoing refractive surgery for correction of ametropia will receive a transepithelial PRK (tPRK) and conventional PRK treatment in the contralateral eye. To avoid bias in the clinical outcomes, the two PRK treatment options are randomized to the eyes of the patients based on ocular dominance. In addition, a 1:1 randomization is applied within the tPRK group to eyes with and without end-treatment laser polishing.

Both procedures, standard PRK and tPRK, are performed in a one-step procedure. The main difference between the procedures is, that in conventional PRK, the epithelium will be removed using alcohol, whereas in tPRK procedures, the epithelium will be removed by laser ablation.

Enrollment: 39 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ametropia
• Myopic subjects with refractive spherical equivalent (MRSE) between -1.5D and -9.0D
• Hyperopic subjects with refractive spherical equivalent (MRSE) between +1.5D and +5.25D
• Signed informed consent form

Exclusion criteria

• Ocular comorbidity
• Subject taking systemic medications likely to affect wound healing such as corticosteroids or antimetabolites.
• Subjects who are known to be pregnant, lactating, or who plans to become pregnant over the medications used for standard tPRK.
• Subjects participating in any other ophthalmic clinical trial during this clinical study.
• Subjects with cognitive impairments or other vulnerable persons

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 3 patient groups

Transepithelial Photorefractive keratectomy (tPRK) without laser polishing

Experimental group

Treatment:

Procedure: Transepithelial Photorefractive keratectomy (tPRK) without laser polishing

Transepithelial Photorefractive keratectomy (tPRK) with laser polishing

Experimental group

Treatment:

Procedure: Transepithelial Photorefractive keratectomy (tPRK) with laser polishing

Standard Photorefractive keratectomy (PRK)

Active Comparator group

Treatment:

Procedure: Standard Photorefractive keratectomy (PRK)