Safety and Efficacity of Corneal Collagen Crosslinking in Infectious Keratitis (Bacterial and Fungal ): Randomized,Controlled, Prospective Study. (CXL)
Information source: Nantes University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Keratitis; Fungal Keratitis
Intervention: Crosslinking (Device); antibiotic treatment (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Nantes University Hospital Overall contact:
Isabelle Orignac, PH, Phone: 02 40 08 34 05, Email: isabelle.orignac@chu-nantes.fr
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.
Clinical Details
Official title: Safety and Efficacity of Corneal Collagen Crosslinking in Infectious Keratitis (Bacterial and Fungal ): Randomized,Controlled, Prospective Study.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Duration of corneal complete epithelial healing in days.
Secondary outcome: Size of the corneal scarCorneal thinning Gain of visual acuity
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Isabelle Orignac, PH, Phone: 02 40 08 34 05, Email: isabelle.orignac@chu-nantes.fr
Orignac, Nantes 44000, France; Recruiting
Isabelle Orignac, PH, Phone: 02 40 08 34 05, Email: isabelle.orignac@chu-nantes.fr
Additional Information
Starting date: September 2014
Last updated: June 5, 2015
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