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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Corneal Ulcer trials