Safety and Efficacy of a New Transepithelial Photorefractive Keratectomy Treatment
Prospective Clinical Study to Evaluate the Safety and Efficacy of a New Transepithelial Photorefractive Keratectomy Treatment
1 other identifier
interventional
39
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2020
CompletedFirst Posted
Study publicly available on registry
January 6, 2021
CompletedStudy Start
First participant enrolled
February 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2022
CompletedOctober 7, 2022
March 1, 2022
1.1 years
October 30, 2020
October 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute refractive predictability
Absolute refractive predictability is the absolute difference between intended and achieved Manifest Refraction Spherical Equivalent (MRSE) between eyes
3 months follow up
Secondary Outcomes (9)
Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
3 months follow up
Monocular Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions
3 months follow up
Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions
3 months follow up
Monocular Corrected Distance Visual Acuity (CDVA) under mesopic light conditions
3 months follow up
Monocular Contrast Sensitivity
3 months follow up
- +4 more secondary outcomes
Other Outcomes (9)
Absolute refractive predictability
6 months follow up
Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
6 months follow up
Monocular Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions
6 months follow up
- +6 more other outcomes
Study Arms (3)
Transepithelial Photorefractive keratectomy (tPRK) without laser polishing
EXPERIMENTALTransepithelial Photorefractive keratectomy (tPRK) with laser polishing
EXPERIMENTALStandard Photorefractive keratectomy (PRK)
ACTIVE COMPARATORInterventions
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) 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.
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asian Eye Institute
Makati City, Philippines
Related Publications (1)
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.
PMID: 40445504DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Ang, MD
Asian Eye Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2020
First Posted
January 6, 2021
Study Start
February 2, 2021
Primary Completion
March 21, 2022
Study Completion
March 21, 2022
Last Updated
October 7, 2022
Record last verified: 2022-03