Safety and Efficacy of a New Transepithelial Photorefractive Keratectomy Treatment
NCT ID: NCT04698174
Last Updated: 2022-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2021-02-02
2022-03-21
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Transepithelial Photorefractive keratectomy (tPRK) without laser polishing
Transepithelial Photorefractive keratectomy (tPRK) without laser polishing
Transepithelial Photorefractive keratectomy (tPRK) with laser ablation of the corneal epithelium and stroma in a single-step procedure using the B+L Teneo 317 Model 2 Excimer Laser.
Transepithelial Photorefractive keratectomy (tPRK) with laser polishing
Transepithelial Photorefractive keratectomy (tPRK) with laser polishing
Transepithelial Photorefractive keratectomy (tPRK) using the B+L Teneo 317 Model 2 Excimer Laser with end-treatment laser polishing using a fixed thickness of the additional layer of 5 μm.
Standard Photorefractive keratectomy (PRK)
Standard Photorefractive keratectomy (PRK)
Conventional Photorefractive keratectomy (PRK) with alcohol-assisted epithelium ablation. Then the aspheric ablation profile will be performed using the B+L Teneo 317 Model 2 Excimer Laser.
Interventions
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Transepithelial Photorefractive keratectomy (tPRK) without laser polishing
Transepithelial Photorefractive keratectomy (tPRK) with laser ablation of the corneal epithelium and stroma in a single-step procedure using the B+L Teneo 317 Model 2 Excimer Laser.
Transepithelial Photorefractive keratectomy (tPRK) with laser polishing
Transepithelial Photorefractive keratectomy (tPRK) using the B+L Teneo 317 Model 2 Excimer Laser with end-treatment laser polishing using a fixed thickness of the additional layer of 5 μm.
Standard Photorefractive keratectomy (PRK)
Conventional Photorefractive keratectomy (PRK) with alcohol-assisted epithelium ablation. Then the aspheric ablation profile will be performed using the B+L Teneo 317 Model 2 Excimer Laser.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Bausch & Lomb Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Ang, MD
Role: PRINCIPAL_INVESTIGATOR
Asian Eye Institute
Locations
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Asian Eye Institute
Makati City, , Philippines
Countries
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References
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Ang RET. Transepithelial Versus Conventional PRK: A Randomized Controlled Study. Ophthalmol Ther. 2025 Jul;14(7):1567-1579. doi: 10.1007/s40123-025-01167-2. Epub 2025 May 30.
Other Identifiers
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BL1902
Identifier Type: -
Identifier Source: org_study_id
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