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

Not Applicable

Completed

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.

Recruitment & Eligibility

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, 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 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.

Arm && Interventions

Group	Intervention	Description
ProKera	ProKera	-
Bandage contact lens	Bandage contact lens	-

Primary Outcome Measures

Name	Time	Method
Number of Days to Complete Re-epithelialization	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

Name	Time	Method
Post-operative Pain Score Ranging From 0 (None) to 10 (Worst Possible Pain)	Day 1	measured subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
Number of Eyes With Complications/Adverse Events	up to one year post-operatively
Number of Eyes Achieving Uncorrected Distance Visual Acuity of 20/20 or Better at 12 Months Post-operatively	one year post-operatively	Uncorrected Distance Visual Acuity
Number of Eyes With Manifest Spherical Equivalent Within +/- 0.50 Diopters of Emmetropia at 12 Months Post-operatively	one year post-operatively	Manifest spherical equivalent within +/- 0.50 diopters of emmetropia
Number of Eyes With Clinically Significant Corneal Haze	one year postoperatively	clinically significant corneal haze (grade 2 or higher)
Tear Total Protein Levels	1 month post-operatively	total protein levels