CompletedPhase 1/2

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

United States61 participantsStarted 2020-07-10

Plain-language summary

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

Age range21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients aged 21 years and older.
✓. Patients undergoing PRK for visual correction in both eyes.
✓. Willing and able to give consent for study participation and comply with study procedures, including follow-up visits.

✕. Patients with any active eye disease, including keratoconus or any other ectactic disorders.
✕. Patients with documented uncontrolled diabetes.
✕. Patients with severe dry eye as measured by corneal staining.
✕. Patients with calculated PRK treatment resulting in residual stromal bed \<300 um.
✕. Patients who have had previous eye surgery or refractive laser procedures.
✕. Patients with any active collagen vascular disease.
✕. Patients who do not have potential of 20/20 or better best corrected vision in each eye.

Safety - Adverse Events Including Serious Adverse Events

Timeframe: Up to 12 months after the last study dose

NCT IDNCT04281004

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-16

Results submitted2024-01-12