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Completed

NCT Number: NCT04281004

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

This is a randomized, double-masked, placebo-controlled study to determine the safety of pAF in patients who undergo PRK.

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Key information

Conditions

Photorefractive Keratectomy

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Moran Eye Center, University of Utah

Salt Lake City, Utah, 84132, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

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

Exclusion:

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

Treatment and study plan

Amniotic Fluid (AFED)

Biological

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

Saline solution

Other

One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days

Primary outcomes

  1. Safety - Adverse Events Including Serious Adverse Events

    Time frame: Up to 12 months after the last study dose

    Ocular adverse events using MedDRA and CTCAE and serious adverse events

Secondary outcomes

  1. Time to Complete Re-epithelization

    Time frame: 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

    Time frame: Post-operative months 1, 3, 6, and 12

    Ophthalmologic assessment to determine uncorrected visual acuity

  3. Pain in Each Eye

    Time frame: Post-operative days 1 - 8

    Patient reported pain using a visual analog scale (VAS) with 0 as no pain and 10 as worst pain

  4. Count of Participants Who Reported Oral Pain Medication Usage

    Time frame: 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.

  5. Corneal Staining in Each Eye

    Time frame: 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).

  6. Corneal Surface Regularity

    Time frame: Post-operative months 1, 3, 6, and 12

    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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

A Phase I/II Randomized, Double-Masked Placebo-Controlled Study For Determining The Safety Of Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2020
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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