Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy
Primary Purpose
Corneal Wound Healing
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ProKera
Bandage contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Wound Healing focused on measuring ProKera, Amniotic membrane, Photorefractive Keratectomy, PRK, time to re-epithelialization
Eligibility 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.
Sites / Locations
- Walter Reed Army Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ProKera
Bandage contact lens
Arm Description
Outcomes
Primary Outcome Measures
Corneal Re-epithelialization
measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy
Secondary Outcome Measures
Post-operative Pain
measured subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
Complications/Adverse Events
Visual Recovery
Long-term Visual Outcomes
Corneal Clarity
Tear Protein Analysis
Full Information
NCT ID
NCT00915759
First Posted
June 5, 2009
Last Updated
July 16, 2014
Sponsor
Walter Reed National Military Medical Center
Collaborators
Tissue Tech Inc., Department of Ophthalmology and Optometry St John's Hospital and Clinics, Proteomics Shared Resource
1. Study Identification
Unique Protocol Identification Number
NCT00915759
Brief Title
Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy
Official Title
Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Walter Reed National Military Medical Center
Collaborators
Tissue Tech Inc., Department of Ophthalmology and Optometry St John's Hospital and Clinics, Proteomics Shared Resource
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Wound Healing
Keywords
ProKera, Amniotic membrane, Photorefractive Keratectomy, PRK, time to re-epithelialization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ProKera
Arm Type
Active Comparator
Arm Title
Bandage contact lens
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
ProKera
Intervention Description
ProKera placed in non-dominant eye after PRK
Intervention Type
Device
Intervention Name(s)
Bandage contact lens
Intervention Description
Bandage contact lens placed in dominant eye, the current standard after PRK
Primary Outcome Measure Information:
Title
Corneal Re-epithelialization
Description
measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy
Time Frame
participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively
Secondary Outcome Measure Information:
Title
Post-operative Pain
Description
measured subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
Time Frame
measured daily until complete re-epithelialization, an expected average of 3-5 days post-operatively
Title
Complications/Adverse Events
Time Frame
one year post-operatively
Title
Visual Recovery
Time Frame
one year post-operatively
Title
Long-term Visual Outcomes
Time Frame
one year post-operatively
Title
Corneal Clarity
Time Frame
one year postoperatively
Title
Tear Protein Analysis
Time Frame
up to 1 month post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard D Stutzman, MD
Organizational Affiliation
WRNMMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy
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