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

NCT ID: NCT00915759

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2015-07-31

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.

Conditions

Corneal Wound Healing

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ProKera

Group Type: ACTIVE_COMPARATOR

ProKera

Intervention Type: DEVICE

ProKera placed in non-dominant eye after photorefractive keratectomy (PRK)

Bandage contact lens

Group Type: PLACEBO_COMPARATOR

Bandage contact lens

Intervention Type: DEVICE

Bandage contact lens placed in dominant eye, the current standard after photorefractive keratectomy (PRK)

Interventions

ProKera

ProKera placed in non-dominant eye after photorefractive keratectomy (PRK)

Intervention Type: DEVICE

Bandage contact lens

Bandage contact lens placed in dominant eye, the current standard after photorefractive keratectomy (PRK)

Intervention Type: DEVICE

Eligibility 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, 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BioTissue Holdings, Inc

INDUSTRY

Sponsor Role: collaborator

St. John's Hospital

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Walter Reed National Military Medical Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard D Stutzman, MD

Role: PRINCIPAL_INVESTIGATOR

WRNMMC

Locations

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

08-6961

Identifier Type: -

Identifier Source: org_study_id