Status:
COMPLETED
Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy (PRK)
Lead Sponsor:
University of Utah
Conditions:
Photorefractive Keratectomy
Eligibility:
All Genders
21+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a randomized, double-masked, placebo-controlled study to determine the safety of pAF in patients who undergo PRK.
Detailed Description
Photorefractive Keratectomy (PRK) is a common elective surgery used to correct refractive errors. We propose that amniotic fluid drops may be beneficial in promoting ocular surface healing following P...
Eligibility Criteria
Inclusion
- Inclusion:
- Patients aged 21 years and older.
- Patients undergoing PRK for visual correction in both eyes.
- Willing and able to give consent for study participation and comply with study procedures, including follow-up visits.
- Exclusion:
- Patients with any active eye disease, including keratoconus or any other ectactic disorders.
- Patients with documented uncontrolled diabetes.
- Patients with severe dry eye as measured by corneal staining.
- Patients with calculated PRK treatment resulting in residual stromal bed \<300 um.
- Patients who have had previous eye surgery or refractive laser procedures.
- Patients with any active collagen vascular disease.
- Patients who do not have potential of 20/20 or better best corrected vision in each eye.
Exclusion
Key Trial Info
Start Date :
July 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2023
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04281004
Start Date
July 10 2020
End Date
January 16 2023
Last Update
April 18 2024
Active Locations (1)
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1
Moran Eye Center, University of Utah
Salt Lake City, Utah, United States, 84132