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

Walter Reed National Military Medical Center

Status

Completed

Conditions

Corneal Wound Healing

Treatments

Device: ProKera

Device: Bandage contact lens

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Industry

Identifiers

NCT00915759

08-6961

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.