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

Bacterial Keratitis Clinical Trial

— CXL  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02088970
• Other study ID #: RC14_0004
• Status: Terminated
• Phase: N/A
• First received: March 13, 2014
• Last updated: May 31, 2017
• Start date: September 2014
• Est. completion date: April 2017

Study information

• Verified date: May 2017
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Keratitis
• Communicable Diseases
• Fungal Keratitis
• Infection
• Keratitis

Intervention

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.

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

Locations

Country	Name	City	State
France	Orignac	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of corneal complete epithelial healing in days.		3 months
Secondary	Size of the corneal scar	Size of the corneal scar at 3months expressed in % of the initial size of the corneal ulcer.	3months
Secondary	Corneal thinning	Corneal thinning estimated by Anterior segment optical coherence tomography at 3 months, expressed in microns.	3 months
Secondary	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