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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
R&D Tissue Tech
Department of Ophthalmology and Optometry St John's Hospital and Clinics
Proteomics Shared Resource
Information provided by (Responsible Party):
Michael J. Mines, MD, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00915759
First received: June 5, 2009
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

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 Intervention
Corneal Wound Healing
Device: ProKera
Device: Bandage contact lens

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:
  • Corneal Re-epithelialization [ Time Frame: participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively ] [ Designated as safety issue: Yes ]
    measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy


Secondary Outcome Measures:
  • 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 ]
  • Tear Protein Analysis [ Time Frame: up to 1 month post-operatively ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: June 2009
Estimated Study Completion Date: December 2013
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915759

Locations
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
Sponsors and Collaborators
Walter Reed Army Medical Center
R&D Tissue Tech
Department of Ophthalmology and Optometry St John's Hospital and Clinics
Proteomics Shared Resource
Investigators
Principal Investigator: Michael J Mines, MD Walter Reed Army Medical Center
  More Information

No publications provided

Responsible Party: Michael J. Mines, MD, Research Director, Ophthalmology, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier: NCT00915759     History of Changes
Other Study ID Numbers: 08-6961
Study First Received: June 5, 2009
Results First Received: May 15, 2013
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:
ProKera
Amniotic membrane
Photorefractive Keratectomy
PRK
time to re-epithelialization

ClinicalTrials.gov processed this record on April 14, 2014