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

NCT ID: NCT04281004

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-10
• Study Completion Date: 2023-01-16

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

Conditions

Photorefractive Keratectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Amniotic Fluid (AFED)

Group Type: ACTIVE_COMPARATOR

Amniotic Fluid (AFED)

Intervention Type: BIOLOGICAL

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

Saline Solution

Group Type: PLACEBO_COMPARATOR

Saline Solution

Intervention Type: OTHER

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

Interventions

Amniotic Fluid (AFED)

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

Intervention Type: BIOLOGICAL

Saline Solution

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Mark Mifflin

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Moran Eye Center, University of Utah

Salt Lake City, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

99569

Identifier Type: -

Identifier Source: org_study_id