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

NCT ID: NCT02088970

Last Updated: 2017-06-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-04-30

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.

Conditions

Bacterial Keratitis; Fungal Keratitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

antibiotic treatment alone

Group Type: ACTIVE_COMPARATOR

antibiotic treatment

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Crosslinking

Intervention Type: DEVICE

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.

antibiotic treatment

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DEVICE

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

Intervention Type: DRUG

Other Intervention 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)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Orignac

Nantes, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 32557558 (View on PubMed)

Other Identifiers

RC14_0004

Identifier Type: -

Identifier Source: org_study_id