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

Nantes University Hospital (NUH)

Status: Terminated

Conditions: Fungal Keratitis; Bacterial Keratitis

Treatments: Device: Crosslinking; Drug: antibiotic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02088970

RC14_0004

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

21 participants in 2 patient groups

antibiotic treatment alone

Active Comparator group

Treatment:

Drug: antibiotic treatment

Crosslinking + Antibiotic

Experimental group

Description:

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.

Treatment:

Drug: antibiotic treatment

Device: Crosslinking