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

Photorefractive Keratectomy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04281004
• Other study ID #: 99569
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 10, 2020
• Est. completion date: January 16, 2023

Study information

• Verified date: April 2024
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 16, 2023
• Est. primary completion date: January 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Photorefractive Keratectomy

Intervention

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

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

Locations

Country	Name	City	State
United States	Moran Eye Center, University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Adverse Events Including Serious Adverse Events	Ocular adverse events using MedDRA and CTCAE and serious adverse events	Up to 12 months after the last study dose
Secondary	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.	Post-operative days 1 - 8
Secondary	Uncorrected Visual Acuity	Ophthalmologic assessment to determine uncorrected visual acuity	Post-operative months 1, 3, 6, and 12
Secondary	Pain in Each Eye	Patient reported pain using a visual analog scale (VAS) with 0 as no pain and 10 as worst pain	Post-operative days 1 - 8
Secondary	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.	Post-operative days 1 - 8
Secondary	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).	Post-operative months 1, 3, 6, and 12
Secondary	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.	Post-operative months 1, 3, 6, and 12