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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
ProKera placed in non-dominant eye after photorefractive keratectomy (PRK)
Bandage contact lens placed in dominant eye, the current standard after photorefractive keratectomy (PRK)
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Number of Days to Complete Re-epithelialization
measured as number of days to complete re-epithelialization, as assessed by daily examination using slit lamp biomicroscopy
Time frame: participants will be followed daily until complete re-epithelialization, an expected average of 3-5 days post-operatively
Post-operative Pain Score Ranging From 0 (None) to 10 (Worst Possible Pain)
measured subjectively using the Visual Analog Scale (VAS) ranging from 0 (none) to 10 (worst possible pain)
Time frame: Day 1
Number of Eyes With Complications/Adverse Events
Time frame: up to one year post-operatively
Number of Eyes Achieving Uncorrected Distance Visual Acuity of 20/20 or Better at 12 Months Post-operatively
Uncorrected Distance Visual Acuity
Time frame: one year post-operatively
Number of Eyes With Manifest Spherical Equivalent Within +/- 0.50 Diopters of Emmetropia at 12 Months Post-operatively
Manifest spherical equivalent within +/- 0.50 diopters of emmetropia
Time frame: one year post-operatively
Number of Eyes With Clinically Significant Corneal Haze
clinically significant corneal haze (grade 2 or higher)
Time frame: one year postoperatively
Tear Total Protein Levels
total protein levels
Time frame: 1 month post-operatively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.