Status:
COMPLETED
Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy
Lead Sponsor:
Walter Reed National Military Medical Center
Collaborating Sponsors:
BioTissue Holdings, Inc
St. John's Hospital
Conditions:
Corneal Wound Healing
Eligibility:
All Genders
21-65 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00915759
Start Date
June 1 2009
End Date
July 1 2015
Last Update
February 7 2025
Active Locations (1)
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1
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307