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

Study Overview
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Brief Summary
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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.

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

Conditions
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Bacterial Keratitis, Fungal Keratitis

Intervention / Treatment
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* Device: Crosslinking
* Drug: antibiotic treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: antibiotic treatment alone<br> | Drug: antibiotic treatment<br>* 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<br>|
| Experimental: Crosslinking + Antibiotic<br>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. | Device: Crosslinking<br>* 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.<br>* Other names: Model : Vega, CBM X Linker. (CSO, Florence, Italie);Drug: antibiotic treatment<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infectious keratitis, Corneal cross linking, Topical antibiotics