Status:
COMPLETED
Safety and Efficacy of a New Transepithelial Photorefractive Keratectomy Treatment
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Ametropia
Eligibility:
All Genders
18-85 years
Phase:
NA
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 ametrop...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2022
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04698174
Start Date
February 2 2021
End Date
March 21 2022
Last Update
October 7 2022
Active Locations (1)
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1
Asian Eye Institute
Makati City, Philippines