Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307, United States
NCT Number: NCT00915759
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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Notify Me21 year–65 year
All sexes
Interventional
Not applicable
Washington D.C., District of Columbia, 20307, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ProKera placed in non-dominant eye after photorefractive keratectomy (PRK)
Bandage contact lens placed in dominant eye, the current standard after photorefractive keratectomy (PRK)
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
Time frame: Day 1
measured subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
Time frame: up to one year post-operatively
Time frame: one year post-operatively
Uncorrected Distance Visual Acuity
Time frame: one year post-operatively
Manifest spherical equivalent within +/- 0.50 diopters of emmetropia
Time frame: one year postoperatively
clinically significant corneal haze (grade 2 or higher)
Time frame: 1 month post-operatively
total protein levels
Walter Reed National Military Medical Center
Fed
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