Clinical trial NCT04281004: Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy (PRK)
Official title: A Phase I/II Randomized, Double-Masked Placebo-Controlled Study For Determining The Safety Of Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Photorefractive Keratectomy
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 61
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion:

1. Patients aged 21 years and older.
2. Patients undergoing PRK for visual correction in both eyes.
3. Willing and able to give consent for study participation and comply with study procedures, including follow-up visits.

Exclusion:

1. Patients with any active eye disease, including keratoconus or any other ectactic disorders.
2. Patients with documented uncontrolled diabetes.
3. Patients with severe dry eye as measured by corneal staining.
4. Patients with calculated PRK treatment resulting in residual stromal bed \<300 um.
5. Patients who have had previous eye surgery or refractive laser procedures.
6. Patients with any active collagen vascular disease.
7. Patients who do not have potential of 20/20 or better best corrected vision in each eye.

Primary outcomes:
measure: Safety - Adverse Events Including Serious Adverse Events
timeFrame: Up to 12 months after the last study dose
Secondary outcomes:
measure: Time to Complete Re-epithelization
timeFrame: Post-operative days 1 - 8
measure: Uncorrected Visual Acuity
timeFrame: Post-operative months 1, 3, 6, and 12
measure: Pain in Each Eye
timeFrame: Post-operative days 1 - 8
measure: Count of Participants Who Reported Oral Pain Medication Usage
timeFrame: Post-operative days 1 - 8
measure: Corneal Staining in Each Eye
timeFrame: Post-operative months 1, 3, 6, and 12
measure: Corneal Surface Regularity
timeFrame: Post-operative months 1, 3, 6, and 12
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Moran Eye Center, University of Utah
state: Utah
Study officials:
References: