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OpenTrials
Completed

NCT Number: NCT00915759

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

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.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ProKera

Device

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

Bandage contact lens

Device

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

Primary outcomes

  1. Number of Days to Complete 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 outcomes

  1. Post-operative Pain Score Ranging From 0 (None) to 10 (Worst Possible Pain)

    Time frame: Day 1

    measured subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)

  2. Number of Eyes With Complications/Adverse Events

    Time frame: up to one year post-operatively

  3. Number of Eyes Achieving Uncorrected Distance Visual Acuity of 20/20 or Better at 12 Months Post-operatively

    Time frame: one year post-operatively

    Uncorrected Distance Visual Acuity

  4. Number of Eyes With Manifest Spherical Equivalent Within +/- 0.50 Diopters of Emmetropia at 12 Months Post-operatively

    Time frame: one year post-operatively

    Manifest spherical equivalent within +/- 0.50 diopters of emmetropia

  5. Number of Eyes With Clinically Significant Corneal Haze

    Time frame: one year postoperatively

    clinically significant corneal haze (grade 2 or higher)

  6. Tear Total Protein Levels

    Time frame: 1 month post-operatively

    total protein levels

Sponsors and collaborators

Lead sponsor

Walter Reed National Military Medical Center

Fed

Collaborators

  • BioTissue Holdings, Inc
  • St. John's Hospital
  • University of Colorado, Denver

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2015
First posted
Jun 8, 2009
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.