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

Utah System of Higher Education (USHE)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Photorefractive Keratectomy

Treatments: Biological: Amniotic Fluid (AFED); Other: Saline Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT04281004

99569

Details and patient eligibility

About

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

Full 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

Enrollment: 61 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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61 participants in 2 patient groups, including a placebo group

Amniotic Fluid (AFED)

Active Comparator group

Treatment:

Biological: Amniotic Fluid (AFED)

Saline Solution

Placebo Comparator group

Treatment:

Other: Saline Solution