The Use of MMC During PRK and Its Effect on Postoperative Topical Steroid Requirements
Corneal Opacity
About this trial
This is an interventional prevention trial for Corneal Opacity focused on measuring photorefractive keratectomy, corneal haze, mitomycin-C, postoperative steroids
Eligibility Criteria
Inclusion Criteria:
- Active duty male or female, of any race, and at least 21 years old at the time of the pre-operative examination, and have signed an informed consent. The lower age limit of 21 is intended to ensure documentation of refractive stability.
- Manifest spherical equivalent (MSE) from +3.00 D to -11.0D with refractive cylinder of up to 3.00 D.
- Best spectacle corrected visual acuity of 20/25 or better in both eyes.
- Stable spectacle refraction, confirmed by clinical records. Neither the spherical nor the cylindrical portion of the refraction may have changed more than 0.50 D during the six-month period immediately preceding the baseline examination for myopic patients and 0.75 for hyperopic patients.
- Contact lens use: Soft contact lenses must have been removed at least two (2) weeks prior to baseline measurements. Hard contact lens users (PMMA or rigid gas permeable lenses) must have removed their lenses at least four (4) weeks prior to baseline measurements.
- Strong motivation for attending the follow-up visits and orders to remain in the area for the duration of at least twelve months of follow up.
- Consent of the subject's command to participate in the study.
- Access to transportation to meet follow up requirements.
Exclusion Criteria:
- Aviators.
- Female subjects who are pregnant, breast-feeding, or intend to become pregnant during the course of the study.
- Concurrent topical or systemic medications which may impair healing, including corticosteroids, antimetabolites, isotretinoin, (Accutane™), amiodarone hydrochloride (Cordarone™), and/or sumatriptan (Imitrex™).
- Medical conditions which, in the judgment of the investigator, may impair healing, including but not limited to thyroid disorders and diabetes.
- Active ophthalmic disease, neovascularization of the cornea within 1 mm of the intended ablation zone, or lens opacity.
- Evidence of glaucoma or an intraocular pressure greater than 22 mm Hg at baseline.
- Evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye.
- Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
- Any physical or mental impairment which would preclude participation in any of the examinations, such as inability to give verbal responses to eye charts.
Sites / Locations
- Navy Warfighter Refractive Surgery Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Mitomycin-C; 3 week FML steroid taper
Mitomycin-C; 1 week FML steroid taper
No mitomycin-C; 8 week FML steroid taper
Mitomycin-C 0.01% will be administered intraoperatively during PRK for 15 seconds. The patient will take a 3 week fluorometholone 1% topical steroid taper.
Mitomycin-C 0.01% will be administered intraoperatively during PRK for 15 seconds. The patient will take a 1 week of fluorometholone 1% topical steroid.
No mitomycin-C will be administered during the procedure. Instead a sham application of salt solution will be given for 15 seconds. The patient will take 8 weeks of topical fluorometholone 1% topical steroid drop taper.