Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy (PRK)
- Conditions
- Photorefractive Keratectomy
- Interventions
- Other: Saline SolutionBiological: Amniotic Fluid (AFED)
- Registration Number
- NCT04281004
- Lead Sponsor
- University of Utah
- 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 PRK. Purified amniotic fluid (pAF) contains anti-inflammatory, anti-microbial and regenerative factors similar to solid amniotic membrane. Individual patients will be randomized to one of two post-operative drop regimens, control eyes that will receive placebo saline solution (NaCl 0.9%, Baxter Medical), and study eyes that will receive pAF four times daily for seven days.
This is a randomized, double-masked, placebo-controlled study to determine
* the safety of pAF in patients who undergo PRK
* if pAF hastens re-epithelialization following PRK compared to placebo
* if pAF reduces post-operative pain following PRK compared to placebo
* if pAF affects visual outcome following PRK compared to placebo
* if pAF affects ocular surface staining and corneal regularity following PRK compared to placebo
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saline Solution Saline Solution - Amniotic Fluid (AFED) Amniotic Fluid (AFED) -
- Primary Outcome Measures
Name Time Method Safety - Adverse Events Including Serious Adverse Events Up to 12 months after the last study dose Ocular adverse events using MedDRA and CTCAE and serious adverse events
- Secondary Outcome Measures
Name Time Method Time to Complete Re-epithelization Post-operative days 1 - 8 Ophthalmologic assessment to determine re-epithelialization. Dimensions of the epithelial defects will be directly measured using slit lamp bio-microscopy. The baseline epithelial defect will be measured by surgeons on Day 1 at the time of surgery. A vertical and horizontal measure of defect in mm will be performed, and defect area calculated. A complete re-epithelization (absence of a defect) is defined when the measures equal zero.
Uncorrected Visual Acuity Post-operative months 1, 3, 6, and 12 Ophthalmologic assessment to determine uncorrected visual acuity
Pain in Each Eye Post-operative days 1 - 8 Patient reported pain using a visual analog scale (VAS) with 0 as no pain and 10 as worst pain
Count of Participants Who Reported Oral Pain Medication Usage Post-operative days 1 - 8 Patient reported oral pain medication usage in the first seven days of post-surgical follow-up (yes/no), where yes corresponds to any use of oral pain medication.
Corneal Staining in Each Eye Post-operative months 1, 3, 6, and 12 Ocular surface staining to determine ocular dryness using an area density index with 16 index options. A0D0 equals no dry eye to A3D3 equals most severe dryness (A=area and D=density).
Corneal Surface Regularity Post-operative months 1, 3, 6, and 12 Surface Regularity Index (SRI) obtained via Zeiss Atlas 9000 Corneal Topographyâ„¢. SRI is a measure of central and paracentral corneal irregularity. A lower SRI suggests more regularity of the anterior surface of the central cornea. Lower values are considered better. The minimum value is 0 and no maximum. And, a value less than 1.55 is considered normal.
Trial Locations
- Locations (1)
Moran Eye Center, University of Utah
🇺🇸Salt Lake City, Utah, United States