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

NCT00915759 | Completed Results

• 1 other identifier: 08-6961
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ProKera; Amniotic membrane; Photorefractive Keratectomy; PRK; time to re-epithelialization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Post-operative Pain Score 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

  one year post-operatively

• Number of Eyes With Manifest Spherical Equivalent Within +/- 0.50 Diopters of Emmetropia at 12 Months Post-operatively

  one year post-operatively

• Number of Eyes With Clinically Significant Corneal Haze

  one year postoperatively

Study Arms (2)

ProKera

ACTIVE COMPARATOR

Device: ProKera

Bandage contact lens

PLACEBO COMPARATOR

Device: Bandage contact lens

Interventions

ProKera DEVICE

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

ProKera

Bandage contact lens DEVICE

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

Bandage contact lens

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead
• BioTissue Holdings, Inc: collaborator
• St. John's Hospital: collaborator
• University of Colorado, Denver: collaborator

Study Sites (1)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

Results Point of Contact

• Title: Principal Investigator
• Organization: Warfighter Refractive Eye Surgery Program and Research Center at FT Belvoir

dha.belvoir.fbch.mbx.wresp-research@health.mil

571-231-1600

Study Officials

• Richard D Stutzman, MD

  WRNMMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2009
• First Posted: June 8, 2009
• Study Start: June 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: July 1, 2015
• Last Updated: February 7, 2025
• Results First Posted: September 20, 2013

Record last verified: 2025-02

Locations

US (1)