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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Photorefractive Keratectomy

• NCT number: NCT04281004
• Study type: Interventional
• Source: University of Utah
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 10, 2020
• Completion date: January 16, 2023