Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-25 @ 5:31 PM
Study NCT ID:
NCT04281004
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2020-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Processed Amniotic Fluid (PAF) Drops After Photorefractive Keratectomy (PRK)
Sponsor:
University of Utah
Organization:
Study Overview
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
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized, double-masked, placebo-controlled study to determine the safety of pAF in patients who undergo PRK.
Detailed 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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: