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Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy

NCT00915759 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-02-07

Study results available
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Summary

The purpose of this study is to evaluate the effect of ProKera on corneal wound healing after photorefractive keratectomy (PRK) in terms of re-epithelialization, pain, adverse effects, visual recovery, refractive accuracy, and corneal clarity.

Conditions

  • Corneal Wound Healing

Interventions

DEVICE

ProKera

ProKera placed in non-dominant eye after photorefractive keratectomy (PRK)

DEVICE

Bandage contact lens

Bandage contact lens placed in dominant eye, the current standard after photorefractive keratectomy (PRK)

Sponsors & Collaborators

  • BioTissue Holdings, Inc

    collaborator INDUSTRY

  • St. John's Hospital

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

  • Walter Reed National Military Medical Center

    lead FED

Principal Investigators

  • Richard D Stutzman, MD · WRNMMC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-11-30
Completion
2015-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00915759 on ClinicalTrials.gov