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Clinical Trial
. 2023 Mar 1;49(3):299-304.
doi: 10.1097/j.jcrs.0000000000001100.

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

Colin S Ip  1 , D Kyle Jones, Eric Weinlander, Brett Gudgel, Amy Lin, Hina Yazdani, Jan Pierce, Richard Holubkov, Hailey Jensen, Myrna Church, Mark D Mifflin
Affiliations
Clinical Trial

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

Colin S Ip et al. J Cataract Refract Surg. .

Abstract

Purpose: To evaluate the safety and efficacy of processed amniotic fluid (pAF) used postoperatively after photorefractive keratectomy (PRK).

Setting: University of Utah, Moran Eye Center, Salt Lake City, Utah.

Design: Randomized, double-masked, placebo-controlled prospective study.

Methods: 61 participants were randomized to receive either placebo or pAF drops, which were instilled 4 times per day for 1 week after PRK along with routine postoperative medications. The primary outcome measure was time to full re-epithelialization in days. Secondary measures included visual acuity at 30 days and postoperative pain scores during the first week.

Results: There was no significant difference in time to re-epithelialization, with a median of 5 days for both groups. There were no difference in pain indicator scores during the first week and no difference in corneal staining scores at day 30 between the 2 groups. There were no adverse events.

Conclusions: This pilot study evaluating the safety and efficacy of pAF as an additional postoperative topical medication for PRK demonstrated that pAF did not improve the rate of epithelial healing after PRK. pAF may be safely studied in other ocular conditions to determine its effect on epithelial healing.

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References

    1. Underwood MA, Gilbert WM, Sherman MP. Amniotic fluid: not just fetal urine anymore. J Perinatol 2005;25:341–348
    1. Gregory DG. New grading system and treatment guidelines for the acute ocular manifestations of Stevens-Johnson syndrome. Ophthalmology 2016;123:1653–1658
    1. Prajna VN, Devi L, Seeniraj SK, Keenan JD. Conjunctival autograft versus amniotic membrane transplantation following double pterygium excision: a randomized trial. Cornea 2017;36:e7–e8
    1. Westekemper H, Figueiredo FC, Siah WF, Wagner N, Steuhl KP, Meller D. Clinical outcomes of amniotic membrane transplantation in the management of acute ocular chemical injury. Br J Ophthalmol 2017;101:103–107
    1. Kim JS, Kim JC, Hahn TW, Park WC. Amniotic membrane transplantation in infectious corneal ulcer. Cornea 2001;20:720–726

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