This is a randomized, double-masked, placebo-controlled study to determine the safety of pAF in patients who undergo PRK.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
61
One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days
One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days
Moran Eye Center, University of Utah
Salt Lake City, Utah, United States
Safety - Adverse Events Including Serious Adverse Events
Ocular adverse events using MedDRA and CTCAE and serious adverse events
Time frame: Up to 12 months after the last study dose
Time to Complete Re-epithelization
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.
Time frame: Post-operative days 1 - 8
Uncorrected Visual Acuity
Ophthalmologic assessment to determine uncorrected visual acuity
Time frame: Post-operative months 1, 3, 6, and 12
Pain in Each Eye
Patient reported pain using a visual analog scale (VAS) with 0 as no pain and 10 as worst pain
Time frame: Post-operative days 1 - 8
Count of Participants Who Reported Oral Pain Medication Usage
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.
Time frame: Post-operative days 1 - 8
Corneal Staining in Each Eye
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).
Time frame: Post-operative months 1, 3, 6, and 12
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Corneal Surface Regularity
Surface Regularity Index (SRI) obtained via Zeiss Atlas 9000 Corneal Topography™. 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.
Time frame: Post-operative months 1, 3, 6, and 12