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

NCT00915759 — Not applicable, Completed, 40 participants, Walter Reed National Military Medical Center

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RegistryNCT00915759
StatusCompleted
PhaseNot applicable
Study typeInterventional; non randomized, single group, masking: none, treatment
Enrollment40 (Actual)
SponsorWalter Reed National Military Medical Center (Fed); collaborators: BioTissue Holdings, Inc, St. John's Hospital, University of Colorado, Denver
ConditionsCorneal Wound Healing
InterventionsProKera, Bandage contact lens (Device)
Datesstart 2009-06-01, primary completion 2010-11-01, completion 2015-07-01, first posted 2009-06-08, last updated 2025-02-07
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Corneal Wound Healing All trials of ProKera All trials of Bandage contact lens

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
ProKeraActive comparatorDevice: ProKera
Bandage contact lensPlacebo comparatorDevice: Bandage contact lens
  • 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)

+Outcome measures

Primary outcomes

  • Number of Days to Complete Re-epithelialization [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

  • Post-operative Pain Score Ranging From 0 (None) to 10 (Worst Possible Pain) [Day 1]: measured subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
  • Number of Eyes With Complications/Adverse Events [up to one year post-operatively]
  • Number of Eyes Achieving Uncorrected Distance Visual Acuity of 20/20 or Better at 12 Months Post-operatively [one year post-operatively]: Uncorrected Distance Visual Acuity
  • Number of Eyes With Manifest Spherical Equivalent Within +/- 0.50 Diopters of Emmetropia at 12 Months Post-operatively [one year post-operatively]: Manifest spherical equivalent within +/- 0.50 diopters of emmetropia
  • Number of Eyes With Clinically Significant Corneal Haze [one year postoperatively]: clinically significant corneal haze (grade 2 or higher)
  • Tear Total Protein Levels [1 month post-operatively]: total protein levels

+Eligibility

Sex: All, ages: 21 Years to 65 Years, accepts healthy volunteers

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.

+Posted results

Participant flow

MilestoneProKera/Bandage Contact Lens
Started40
Completed40
Not completed0

Outcome results

  • Number of Days to Complete Re-epithelialization (Primary), Mean, days to complete re-epithelialization: ProKera 4.6 +/- 1.6; Bandage Contact Lens 4.1 +/- 1.4
  • Number of Days to Complete Re-epithelialization (Primary), Mean, days to complete re-epithelialization: ProKera 5.2 +/- 3.5; Bandage Contact Lens 3.9 +/- 1.1
  • Number of Days to Complete Re-epithelialization (Primary), Mean, days to complete re-epithelialization: ProKera 4.0 +/- 0.8; Bandage Contact Lens 3.8 +/- 0.5
  • Post-operative Pain Score Ranging From 0 (None) to 10 (Worst Possible Pain) (Secondary), Mean, VAS score: ProKera 4.6 +/- 3.3; Bandage Contact Lens 4.8 +/- 2.5
  • Number of Eyes With Complications/Adverse Events (Secondary), Count of units, eye: ProKera 1; Bandage Contact Lens 0
  • Number of Eyes Achieving Uncorrected Distance Visual Acuity of 20/20 or Better at 12 Months Post-operatively (Secondary), Count of units, eyes: ProKera 34; Bandage Contact Lens 35
  • Number of Eyes With Manifest Spherical Equivalent Within +/- 0.50 Diopters of Emmetropia at 12 Months Post-operatively (Secondary), Count of units, eyes: ProKera 32; Bandage Contact Lens 30
  • Number of Eyes With Clinically Significant Corneal Haze (Secondary), Count of units, eyes: ProKera 0; Bandage Contact Lens 0
  • Tear Total Protein Levels (Secondary), Mean, mg/ml: ProKera 9.6 +/- 0.9; Bandage Contact Lens 9.9 +/- 0.8

Adverse events

Time frame: 1 year

ArmDeathsSerious adverse eventsOther adverse events
ProKera0/40 (0.0%)0/40 (0.0%)9/40 (22.5%)
Bandage Contact Lens0/40 (0.0%)0/40 (0.0%)4/40 (10.0%)

Other adverse events by term

TermOrgan systemProKeraBandage Contact Lens
Acute non-granulomatous anterior uveitisEye disorders1/400/40
Spontaneous extrusion of the graft (or BCL) at first postop weekEye disorders1/400/40
Delayed epithelial healing in early postopEye disorders1/400/40
Persistent epithelial defect in early postopEye disorders2/400/40
corneal infiltrates (inflammatory) in early postopEye disorders4/404/40

+Locations (1)

FacilityCityCountryStatus
Walter Reed Army Medical CenterWashington D.C., District of ColumbiaUnited States

+Investigators