Phase 2
N=61
Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy (PRK)
Photorefractive Keratectomy
Bottom Line
View on ClinicalTrials.gov: NCT04281004 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Safety - Adverse Events Including Serious Adverse Events — 1; 1 Participants — p=1.000
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Amniotic Fluid (AFED) (Biological); Saline Solution (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety - Adverse Events Including Serious Adverse Events |
1; 1 | 1.000 |
| SECONDARY Time to Complete Re-epithelization |
5; 5 | 0.869 |
| SECONDARY Uncorrected Visual Acuity |
-0.03; 0.04; -0.06; -0.05; -0.07; -0.06 | 0.007 sig |
| SECONDARY Pain in Each Eye |
4; 5 | 0.614 |
| SECONDARY Count of Participants Who Reported Oral Pain Medication Usage |
26; 31 | 0.594 |
| SECONDARY Corneal Staining in Each Eye |
33; 42; 18; 15; 1; 3 | 0.663 |
| SECONDARY Corneal Surface Regularity |
1.34; 1.58; 1.11; 1.07; 1.07; 0.97 | 0.057 |
Summary
This is a randomized, double-masked, placebo-controlled study to determine the safety of pAF in patients who undergo PRK.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04281004). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.