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

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

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.

Study Overview

• Status: Terminated
• Conditions: Bacterial Keratitis; Fungal Keratitis
• Intervention / Treatment: Drug: antibiotic treatment; Device: Crosslinking

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44000
    • Orignac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: antibiotic treatment alone	Drug: antibiotic treatment; If not the contact lens wearer -> Cocci Gram positive cocci; Vancomycin + Fortum If contact lens wearer -> Gram negative bacillus; Fortum + Amiklin If corticosteroids, immunosuppression, latent evolution -> Fungus. = Fortum + vancomycin + Fungizone
Experimental: Crosslinking + Antibiotic; 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.	Drug: antibiotic treatment; If not the contact lens wearer -> Cocci Gram positive cocci; Vancomycin + Fortum If contact lens wearer -> Gram negative bacillus; Fortum + Amiklin If corticosteroids, immunosuppression, latent evolution -> Fungus. = Fortum + vancomycin + Fungizone; Device: 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.; Other Names: Riboflavine 0,1%.; Ricrolin.; CE 0037.; médical device class IIb.; Manufacter : SOOFT Distributor : Horus pharma.; transmitter UV-A :; Model : Vega, CBM X Linker. (CSO, Florence, Italie)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Duration of corneal complete epithelial healing in days.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Size of the corneal scar	Size of the corneal scar at 3months expressed in % of the initial size of the corneal ulcer.	3months
Corneal thinning	Corneal thinning estimated by Anterior segment optical coherence tomography at 3 months, expressed in microns.	3 months
Gain of visual acuity	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.	3 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Publications and helpful links

General Publications

• Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: March 13, 2014
• First Submitted That Met QC Criteria: March 13, 2014
• First Posted (Estimate): March 17, 2014

Study Record Updates

• Last Update Posted (Actual): June 1, 2017
• Last Update Submitted That Met QC Criteria: May 31, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Topical antibiotics; Infectious keratitis; Corneal cross linking
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease Attributes; Corneal Diseases; Infections; Communicable Diseases; Keratitis; Physiological Effects of Drugs; Anti-Infective Agents; Photosensitizing Agents; Dermatologic Agents; Micronutrients; Vitamins; Vitamin B Complex; Anti-Bacterial Agents; Riboflavin
• Other Study ID Numbers: RC14_0004