Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy (PRK)

Sponsor
University of Utah (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04281004
Collaborator
(none)
61
1
2
35.7
1.7

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
  • Biological: Amniotic Fluid (AFED)
  • Other: Saline Solution
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

  • 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 Design

Study Type:
Interventional
Actual Enrollment :
61 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 10, 2020
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Amniotic Fluid (AFED)

Biological: Amniotic Fluid (AFED)
One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days

Placebo Comparator: Saline Solution

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

  1. 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

  1. 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.

  2. Uncorrected Visual Acuity [Post-operative day 8, and months 1, 3, 6, and 12]

    Ophthalmologic assessment to determine uncorrected visual acuity

  3. 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.

  4. 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

  5. Timing and frequency of use of rescue pain medication [Post-operative days 1 - 8]

    Patient reported oral pain medication usage

  6. 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).

  7. 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

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 bestcorrected vision in each eye.

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Mark Mifflin, MD, University of Utah
ClinicalTrials.gov Identifier:
NCT04281004
Other Study ID Numbers:
  • 99569
First Posted:
Feb 21, 2020
Last Update Posted:
Feb 8, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 8, 2022