Phase I/II randomized, double-masked, placebo-controlled study of processed amniotic fluid drops after PRK

Area of Science:

• Ophthalmology
• Regenerative Medicine
• Corneal Surgery

Background:

• Photorefractive keratectomy (PRK) is a common refractive surgery.
• Postoperative healing and patient comfort are key concerns after PRK.
• Processed amniotic fluid (pAF) is being explored for its potential therapeutic properties.

Purpose of the Study:

• To assess the safety and efficacy of processed amniotic fluid (pAF) as a postoperative treatment for photorefractive keratectomy (PRK).
• To determine if pAF improves epithelial healing rates and reduces pain after PRK.

Main Methods:

• A randomized, double-masked, placebo-controlled prospective study involving 61 participants.
• Participants received either pAF drops or placebo 4 times daily for 1 week post-PRK.
• Primary outcome: time to full re-epithelialization; Secondary outcomes: visual acuity and pain scores.

Main Results:

• No significant difference in the median time to re-epithelialization (5 days) between pAF and placebo groups.
• No significant differences in postoperative pain scores or corneal staining at 30 days.
• No adverse events were reported during the study period.

Conclusions:

• Processed amniotic fluid (pAF) did not demonstrate improved epithelial healing rates after PRK in this pilot study.
• pAF was found to be safe for use as an additional topical medication post-PRK.
• Further investigation of pAF in other ocular conditions is warranted to evaluate its effect on epithelial healing.