CompletedPhase 3

Cross-linking for Corneal Ulcers Treatment Trial

United States, India147 participantsStarted 2015-11

Plain-language summary

The primary purpose of this study is to determine if patients randomized to corneal collagen cross-linking plus medical therapy will have a lower prevalence of positive bacterial or fungal cultures immediately after the procedure than patients who received medical therapy alone. The secondary purpose of this study is to determine if patients randomized to corneal collagen cross-linking will have a better visual acuity at 3 and 12 months than patients who receive medical therapy alone.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * Corneal ulcer that is smear positive for either bacteria or filamentous fungus * Pinhole visual acuity worse than 20/70 in the affected eye * Not treated already with antimicrobial medications at presentation * Age over 18 years * Basic understanding of the study as determined by the physician * Commitment to return for follow up visits Exclusion criteria: * Evidence of concomitant infection on exam or gram stain (i.e. herpes, both bacteria and acanthamoeba on gram stain) * Impending or frank perforation at recruitment * Involvement of sclera at presentation * Non-infectious or autoimmune keratitis * History of corneal transplantation or recent intraocular surgery * No light perception in the affected eye * Pinhole visual acuity worse than 20/200 in the unaffected eye * Participants who are decisionally and/or cognitively impaired

What they're measuring

Microbiological Cure on Repeat Culture

Timeframe: 4 to 24 hours after enrollment

Trial details

NCT IDNCT02570321

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-06-18

Results submitted2023-10-09