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

• ClinicalTrials.gov Identifier: NCT00915759
• Recruitment Status: Unknown
• First Posted: June 8, 2009
• Results First Posted: September 20, 2013
• Last Update Posted: July 25, 2014
• Sponsor: Walter Reed National Military Medical Center
• Collaborators: Tissue Tech Inc.; Department of Ophthalmology and Optometry St John's Hospital and Clinics; Proteomics Shared Resource
• Information provided by (Responsible Party): Samanta B. Rodgers, Fort Belvoir Community Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Corneal Wound Healing	Device: ProKera; Device: Bandage contact lens	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy
• Study Start Date: June 2009
• Actual Primary Completion Date: November 2010
• Estimated Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: ProKera	Device: ProKera; ProKera placed in non-dominant eye after PRK
Placebo Comparator: Bandage contact lens	Device: Bandage contact lens; Bandage contact lens placed in dominant eye, the current standard after PRK

Outcome Measures

Primary Outcome Measures :

1. Corneal Re-epithelialization [ Time Frame: 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, District of Columbia

Walter Reed Army Medical Center

Washington, District of Columbia, United States, 20307

Sponsors and Collaborators

Walter Reed National Military Medical Center

Tissue Tech Inc.

Department of Ophthalmology and Optometry St John's Hospital and Clinics

Proteomics Shared Resource

Investigators

• Principal Investigator: Richard D Stutzman, MD; WRNMMC

More Information

• Responsible Party: Samanta B. Rodgers, Assistant Research Director, Warfighter Refractive Eye Surgery Program and Research Center at FT Belvoir, Fort Belvoir Community Hospital
• ClinicalTrials.gov Identifier: NCT00915759
• Other Study ID Numbers: 08-6961
• First Posted: June 8, 2009
• Results First Posted: September 20, 2013
• Last Update Posted: July 25, 2014
• Last Verified: July 2014

Keywords provided by Samanta B. Rodgers, Fort Belvoir Community Hospital:

ProKera; Amniotic membrane; Photorefractive Keratectomy; PRK; time to re-epithelialization

Additional relevant MeSH terms:

Wounds and Injuries