Overview

This trial is active, not recruiting.

Condition corneal wound healing
Treatments prokera, bandage contact lens
Sponsor Walter Reed Army Medical Center
Collaborator Tissue Tech Inc.
Start date June 2009
End date November 2010
Trial size 40 participants
Trial identifier NCT00915759, 08-6961

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
prokera
ProKera placed in non-dominant eye after PRK
(Placebo Comparator)
bandage contact lens
Bandage contact lens placed in dominant eye, the current standard after PRK

Primary Outcomes

Measure
Corneal Re-epithelialization
time frame: participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively

Secondary Outcomes

Measure
Post-operative Pain
time frame: measured daily until complete re-epithelialization, an expected average of 3-5 days post-operatively
Complications/Adverse Events
time frame: one year post-operatively
Visual Recovery
time frame: one year post-operatively
Long-term Visual Outcomes
time frame: one year post-operatively
Corneal Clarity
time frame: one year postoperatively
Tear Protein Analysis
time frame: up to 1 month post-operatively

Eligibility Criteria

Male or female participants from 21 years up to 65 years old.

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.

Additional Information

Official title Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy
Principal investigator Michael J Mines, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by Walter Reed Army Medical Center.