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

Sponsor

Nantes University Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT02088970

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Keratitis Fungal Keratitis	Device: Crosslinking Drug: antibiotic treatment	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Apr 1, 2017

Actual Study Completion Date :

Apr 1, 2017

Arms and Interventions

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.	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) 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

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.

Device: Crosslinking

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)

Drug: antibiotic treatment

Outcome Measures

Primary Outcome Measures

Duration of corneal complete epithelial healing in days. [3 months]

Secondary Outcome Measures

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.