Clinical trial NCT00915759: Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy
Official title: Sutureless Cryopreserved Amniotic Membrane Graft (ProKera) and Wound Healing After Photorefractive Keratectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Wound Healing
Keywords: ProKera
Amniotic membrane
Photorefractive Keratectomy
PRK
time to re-epithelialization
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
Collaborators: name: BioTissue Holdings, Inc
name: St. John's Hospital
name: University of Colorado, Denver
First posted: 2009-06-08
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Days to Complete Re-epithelialization
timeFrame: participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively
Secondary outcomes:
measure: Post-operative Pain Score Ranging From 0 (None) to 10 (Worst Possible Pain)
timeFrame: Day 1
measure: Number of Eyes With Complications/Adverse Events
timeFrame: up to one year post-operatively
measure: Number of Eyes Achieving Uncorrected Distance Visual Acuity of 20/20 or Better at 12 Months Post-operatively
timeFrame: one year post-operatively
measure: Number of Eyes With Manifest Spherical Equivalent Within +/- 0.50 Diopters of Emmetropia at 12 Months Post-operatively
timeFrame: one year post-operatively
measure: Number of Eyes With Clinically Significant Corneal Haze
timeFrame: one year postoperatively
measure: Tear Total Protein Levels
timeFrame: 1 month post-operatively
Other outcomes:
Locations:
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
Study officials:
affiliation: WRNMMC
name: Richard D Stutzman, MD
role: PRINCIPAL_INVESTIGATOR
References: