TerminatedNot Applicable

Safety and Efficacity of Corneal Collagen Crosslinking in Infectious Keratitis (Bacterial and Fungal ): Randomized,Controlled, Prospective Study. (CXL)

Stopped: Difficulties in reaching the desired number of patients and intermediate analysis leading to discontinuation of the study.

France21 participantsStarted 2014-09

Plain-language summary

The corneal collagen cross linking is currently used in the treatment of keratoconus but this procedure has also a sterilizing non-specific effect on bacteria and fungus. So the corneal cross linking in association with the antibiotic treatment could result in a reduction of the duration of epithelial complete healing of the cornea.

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: * Infectious bacterial or fungal keratitis with : size \> 2mm or within the central corneal area ( 3mm of the visual axis ) or with a reaction in anterior chamber. * Being major responsible. * Agreement in writing to participate in the study. * Being affiliated to a national insurance scheme. Exclusion Criteria: * Present an infectious keratitis without all the previous criteria. * Herpes or acanthamoeba keratitis * preperforated or perforated cornea. General criteria: * Pregnant woman. * Minors(miners). * Adults under guardianship. * Patient can not be followed during 3 necessary months. * French speaking patient. * Unaffiliated patient in a national insurance scheme. * HIV infected patients

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

Duration of corneal complete epithelial healing in days.

Timeframe: 3 months

Trial details

NCT IDNCT02088970

SponsorNantes University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-04

View on ClinicalTrials.gov More Bacterial Keratitis trials