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

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ClinicalTrials.gov Identifier: NCT00915759
Recruitment Status : Unknown
Verified July 2014 by Samanta B. Rodgers, Fort Belvoir Community Hospital.
Recruitment status was:  Active, not recruiting
First Posted : June 8, 2009
Results First Posted : September 20, 2013
Last Update Posted : July 25, 2014
Sponsor:
Collaborators:
Tissue Tech Inc.
Department of Ophthalmology and Optometry St John's Hospital and Clinics
Proteomics Shared Resource
Information provided by (Responsible Party):
Samanta B. Rodgers, Fort Belvoir Community Hospital

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.

Condition or disease Intervention/treatment
Corneal Wound Healing Device: ProKera Device: Bandage contact lens

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy
Study Start Date : June 2009
Primary Completion Date : November 2010
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: ProKera Device: ProKera
ProKera placed in non-dominant eye after PRK
Placebo Comparator: Bandage contact lens Device: Bandage contact lens
Bandage contact lens placed in dominant eye, the current standard after PRK



Primary Outcome Measures :
  1. Corneal Re-epithelialization [ Time Frame: participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively ]
    measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy


Secondary Outcome Measures :
  1. Post-operative Pain [ Time Frame: measured daily until complete re-epithelialization, an expected average of 3-5 days post-operatively ]
    measured subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)

  2. Complications/Adverse Events [ Time Frame: one year post-operatively ]
  3. Visual Recovery [ Time Frame: one year post-operatively ]
  4. Long-term Visual Outcomes [ Time Frame: one year post-operatively ]
  5. Corneal Clarity [ Time Frame: one year postoperatively ]
  6. Tear Protein Analysis [ Time Frame: up to 1 month post-operatively ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 DC 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915759


Locations
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
Sponsors and Collaborators
Walter Reed National Military Medical Center
Tissue Tech Inc.
Department of Ophthalmology and Optometry St John's Hospital and Clinics
Proteomics Shared Resource
Investigators
Principal Investigator: Richard D Stutzman, MD WRNMMC

Responsible Party: Samanta B. Rodgers, Assistant Research Director, Warfighter Refractive Eye Surgery Program and Research Center at FT Belvoir, Fort Belvoir Community Hospital
ClinicalTrials.gov Identifier: NCT00915759     History of Changes
Other Study ID Numbers: 08-6961
First Posted: June 8, 2009    Key Record Dates
Results First Posted: September 20, 2013
Last Update Posted: July 25, 2014
Last Verified: July 2014

Keywords provided by Samanta B. Rodgers, Fort Belvoir Community Hospital:
ProKera
Amniotic membrane
Photorefractive Keratectomy
PRK
time to re-epithelialization

Additional relevant MeSH terms:
Wounds and Injuries