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

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.

Study Overview

• Status: Completed
• Conditions: Corneal Wound Healing
• Intervention / Treatment: Device: ProKera; Device: Bandage contact lens

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20307
      • Walter Reed Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Active duty US Army Soldiers eligible for care at WRAMC.
• Male or female, of any race, and at least 21 years old at the time of the preoperative examination, and have signed and informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
• Subject must expect to be located in the greater Washington, District of Columbia area for a 12 month period post-operatively.
• Consent of the subject's command (active duty) to participate in the study.
• Access to transportation to meet follow-up requirements.

Exclusion Criteria:

• Any reason to be excluded for PRK.
• Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. Female subjects will be give a urine pregnancy test prior to participating in the study to rule out pregnancy. [Pregnancy and breastfeeding are contraindications to refractive surgery in general, including PRK, whether participating in this study or not].
• Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
• Any physical or mental impairment that would preclude participation in any of the examinations.
• Anterior basement membrane dystrophy.
• History of recurrent epithelial erosion.
• Significant dry eye (symptomatic with Schirmer test < 5 mm at 5 minutes).
• Other corneal epithelial disorder or healing abnormality.
• Patients with unusually tight eyelids close to the eyeball making it difficult and/ or painful to insert anything (e.g., ProKera) between the eyelid and globe.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ProKera	Device: ProKera; ProKera placed in non-dominant eye after photorefractive keratectomy (PRK)
Placebo Comparator: Bandage contact lens	Device: Bandage contact lens; Bandage contact lens placed in dominant eye, the current standard after photorefractive keratectomy (PRK)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Days to Complete Re-epithelialization	measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy	participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Pain Score Ranging From 0 (None) to 10 (Worst Possible Pain)	measured subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)	Day 1
Number of Eyes With Complications/Adverse Events		up to one year post-operatively
Number of Eyes Achieving Uncorrected Distance Visual Acuity of 20/20 or Better at 12 Months Post-operatively	Uncorrected Distance Visual Acuity	one year post-operatively
Number of Eyes With Manifest Spherical Equivalent Within +/- 0.50 Diopters of Emmetropia at 12 Months Post-operatively	Manifest spherical equivalent within +/- 0.50 diopters of emmetropia	one year post-operatively
Number of Eyes With Clinically Significant Corneal Haze	clinically significant corneal haze (grade 2 or higher)	one year postoperatively
Tear Total Protein Levels	total protein levels	1 month post-operatively

Collaborators and Investigators

• Sponsor: Walter Reed National Military Medical Center
• Collaborators: University of Colorado, Denver; BioTissue Holdings, Inc; St. John's Hospital
• Investigators: Principal Investigator: Richard D Stutzman, MD, WRNMMC

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: June 5, 2009
• First Submitted That Met QC Criteria: June 5, 2009
• First Posted (Estimated): June 8, 2009

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: PRK; Amniotic membrane; Photorefractive Keratectomy; ProKera; time to re-epithelialization
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 08-6961