Prospective Clinical Study to Evaluate the Safety and Efficacy of a New Transepithelial Photorefractive Keratectomy Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Absolute refractive predictability
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Absolute refractive predictability
Time Frame: 3 months follow up
Absolute refractive predictability is the absolute difference between intended and achieved Manifest Refraction Spherical Equivalent (MRSE) between eyes
Secondary Outcomes
- Monocular Corrected Distance Visual Acuity (CDVA) 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 mesopic light conditions(3 months follow up)
- Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions(3 months follow up)
- Halo Photic phenomena(3 months follow up)
- Glare Photic phenomena(3 months follow up)
- Monocular Contrast Sensitivity(3 months follow up)
- Visual perception scale(3 months follow up)
- Corneal pain(3 months follow up)