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

• post-operative pain [ Time Frame: measured daily until complete re-epithelialization, an expected average of 3-5 days post-operatively ] [ Designated as safety issue: No ]
  measured subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
• complications/adverse events [ Time Frame: one year post-operatively ] [ Designated as safety issue: Yes ]
• visual recovery [ Time Frame: one year post-operatively ] [ Designated as safety issue: Yes ]
• long-term visual outcomes [ Time Frame: one year post-operatively ] [ Designated as safety issue: No ]
• corneal clarity [ Time Frame: one year postoperatively ] [ Designated as safety issue: No ]
• proteomic analysis

• post-operative pain
• complications/adverse events
• visual recovery
• long-term visual outcomes
• corneal clarity
• proteomic analysis

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.

• Device: ProKera
  ProKera placed in non-dominant eye after PRK
• Device: Bandage contact lens
  Bandage contact lens placed in dominant eye, the current standard after PRK

• Active Comparator: ProKera
  Intervention: Device: ProKera
• Placebo Comparator: Bandage contact lens
  Intervention: Device: Bandage contact lens

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.

• R&D Tissue Tech
• Department of Ophthalmology and Optometry St John's Hospital and Clinics
• Proteomics Shared Resource