Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy (PRK)
Study Details
Study Description
Brief Summary
This is a randomized, double-masked, placebo-controlled study to determine the safety of pAF in patients who undergo PRK.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1/Phase 2 |
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
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the safety of pAF in patients who undergo PRK
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if pAF hastens re-epithelialization following PRK compared to placebo
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if pAF reduces post-operative pain following PRK compared to placebo
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if pAF affects visual outcome following PRK compared to placebo
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if pAF affects ocular surface staining and corneal regularity following PRK compared to placebo
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Amniotic Fluid (AFED)
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Biological: Amniotic Fluid (AFED)
One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days
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Placebo Comparator: Saline Solution
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Other: Saline Solution
One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 day 8, and months 1, 3, 6, and 12]
Ophthalmologic assessment to determine uncorrected visual acuity
- Manifest refraction and best-corrected visual acuity [Post-operative months 1, 3, 6, and 12]
Ophthalmologic assessment to determine manifest refraction and best-corrected 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
- Timing and frequency of use of rescue pain medication [Post-operative days 1 - 8]
Patient reported oral pain medication usage
- 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 Topography™
Eligibility Criteria
Criteria
Inclusion:
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Patients aged 21 years and older.
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Patients undergoing PRK for visual correction in both eyes.
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Willing and able to give consent for study participation and comply with study procedures, including follow-up visits.
Exclusion:
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Patients with any active eye disease, including keratoconus or any other ectactic disorders.
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Patients with documented uncontrolled diabetes.
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Patients with severe dry eye as measured by corneal staining.
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Patients with calculated PRK treatment resulting in residual stromal bed <300 um.
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Patients who have had previous eye surgery or refractive laser procedures.
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Patients with any active collagen vascular disease.
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Patients who do not have potential of 20/20 or better bestcorrected vision in each eye.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Moran Eye Center, University of Utah | Salt Lake City | Utah | United States | 84132 |
Sponsors and Collaborators
- University of Utah
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 99569