- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00915759
Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy
July 16, 2014 updated by: Samanta B. Rodgers, Walter Reed National Military Medical Center
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
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20307
- Walter Reed Army Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ProKera
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ProKera placed in non-dominant eye after PRK
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Placebo Comparator: Bandage contact lens
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Bandage contact lens placed in dominant eye, the current standard after PRK
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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)
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measured daily until complete re-epithelialization, an expected average of 3-5 days post-operatively
|
Complications/Adverse Events
Time Frame: one year post-operatively
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one year post-operatively
|
|
Visual Recovery
Time Frame: one year post-operatively
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one year post-operatively
|
|
Long-term Visual Outcomes
Time Frame: one year post-operatively
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one year post-operatively
|
|
Corneal Clarity
Time Frame: one year postoperatively
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one year postoperatively
|
|
Tear Protein Analysis
Time Frame: up to 1 month post-operatively
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up to 1 month post-operatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Richard D Stutzman, MD, WRNMMC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
November 1, 2010
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
June 5, 2009
First Submitted That Met QC Criteria
June 5, 2009
First Posted (Estimate)
June 8, 2009
Study Record Updates
Last Update Posted (Estimate)
July 25, 2014
Last Update Submitted That Met QC Criteria
July 16, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-6961
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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