A Phase 2/3 interventional study of Mitomycin-C and Fluorometholone 1% topical ocular steroid in Corneal Opacity, sponsored by United States Naval Medical Center, San Diego. Status unknown at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-15.
Sponsored by United States Naval Medical Center, San Diego · Phase 2/3, Interventional, and Prevention
The patients will complete a voluntary questionnaire that evaluates their subjective impression of the refractive surgery, their recovery and their outcomes. Specifically, the patient will report the use of refractive correction, usefulness of the surgery at work, dry eye complaints, and subjective appraisal of their vision.
37 studies on the registry are indexed under Corneal Opacity; 5 are open to participants now.
This study's planned enrollment of 300 is above the median of 27 across 20 interventional studies indexed under Corneal Opacity.
Browse Corneal Opacity studies →United States Naval Medical Center, San Diego is the lead sponsor of 65 studies on the registry; 6 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Mitomycin-C · Drug: Fluorometholone 1% topical ocular steroid
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.
Drug: Mitomycin-C · Drug: Fluorometholone 1% topical ocular 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.
Drug: Fluorometholone 1% topical ocular steroid
0.01% applied to cornea with a sponge during PRK
Also known as: MMC
topical steroid drops applied to the cornea after PRK
Also known as: FML
Refractive Error
Objective refractive error with Wavescan Aberrometry
Time frame: 12 months
Refractive Error
Manifest refraction by patient subjective report
Time frame: 12 months
Corneal haze
Subjective grading by slit lamp examiner
Time frame: 12 months
Corneal haze
Subclinical objective measurement of corneal haze by Pentacam densitometry
Time frame: 12 months
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mitomycin
United States Naval Medical Center, San Diego