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

Not Applicable

Terminated

• Conditions: Bacterial Keratitis; Fungal Keratitis
• Interventions: Drug: antibiotic treatment; Device: Crosslinking

• Registration Number: NCT02088970
• Lead Sponsor: Nantes University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-13
• Study First Submitted QC: 2014-03-13
• Study First Posted: 2014-03-17
• Study Start: 2014-09
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-31
• Last Update Posted: 2017-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
antibiotic treatment alone	antibiotic treatment	-
Crosslinking + Antibiotic	Crosslinking	The procedure of the cross linking is standard:combined riboflavin(Ricrolin®)-ultraviolet type A rays (UVA) collagen cross-linking. Radiant energy was 3 milliwatts/cm2 or 5.4 joule/cm2 for a 30-minute exposure irradiation of the cornea. Patients are checked every days during the hospitalisation and one week, one month and 3 months after the hospitalisation.
Crosslinking + Antibiotic	antibiotic treatment	The procedure of the cross linking is standard:combined riboflavin(Ricrolin®)-ultraviolet type A rays (UVA) collagen cross-linking. Radiant energy was 3 milliwatts/cm2 or 5.4 joule/cm2 for a 30-minute exposure irradiation of the cornea. Patients are checked every days during the hospitalisation and one week, one month and 3 months after the hospitalisation.

Primary Outcome Measures

Name	Time	Method
Duration of corneal complete epithelial healing in days.	3 months

Secondary Outcome Measures

Name	Time	Method
Gain of visual acuity	3 months	Gain of visual acuity, corresponding to the difference between the initial visual acuity and the 3months one. The visual acuity is measured with monoyer scale and converted in log Mar.
Size of the corneal scar	3months	Size of the corneal scar at 3months expressed in % of the initial size of the corneal ulcer.
Corneal thinning	3 months	Corneal thinning estimated by Anterior segment optical coherence tomography at 3 months, expressed in microns.

Trial Locations

Locations (1)

Orignac; 🇫🇷 Nantes, France