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

Study Overview
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Brief Summary
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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.

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

Conditions
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Corneal Wound Healing

Intervention / Treatment
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* Device: ProKera
* Device: Bandage contact lens


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ProKera<br> | Device: ProKera<br>* ProKera placed in non-dominant eye after PRK<br>|
| Placebo Comparator: Bandage contact lens<br> | Device: Bandage contact lens<br>* Bandage contact lens placed in dominant eye, the current standard after PRK<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Pain | measured subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain) | measured daily until complete re-epithelialization, an expected average of 3-5 days post-operatively | 
| Complications/Adverse Events |  | one year post-operatively | 
| Visual Recovery |  | one year post-operatively | 
| Long-term Visual Outcomes |  | one year post-operatively | 
| Corneal Clarity |  | one year postoperatively | 
| Tear Protein Analysis |  | up to 1 month post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ProKera, Amniotic membrane, Photorefractive Keratectomy, PRK, time to re-epithelialization