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

• ClinicalTrials.gov Identifier: NCT02088970
• Recruitment Status: Terminated
• First Posted: March 17, 2014
• Last Update Posted: June 1, 2017
• Sponsor: Nantes University Hospital
• Information provided by (Responsible Party): Nantes University Hospital

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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: September 2014
• Actual Primary Completion Date: April 2017
• Actual Study Completion Date: April 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

Outcome Measures

Primary Outcome Measures :

1. Duration of corneal complete epithelial healing in days. [ Time Frame: 3 months ]

Secondary Outcome Measures :

1. Size of the corneal scar [ Time Frame: 3months ]
   Size of the corneal scar at 3months expressed in % of the initial size of the corneal ulcer.
2. Corneal thinning [ Time Frame: 3 months ]
   Corneal thinning estimated by Anterior segment optical coherence tomography at 3 months, expressed in microns.
3. Gain of visual acuity [ Time Frame: 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

France

Orignac

Nantes, France, 44000

Sponsors and Collaborators

Nantes University Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6:CD013001. doi: 10.1002/14651858.CD013001.pub2.

• Responsible Party: Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT02088970
• Other Study ID Numbers: RC14_0004
• First Posted: March 17, 2014
• Last Update Posted: June 1, 2017
• Last Verified: May 2017

Keywords provided by Nantes University Hospital:

Infectious keratitis; Corneal cross linking; Topical antibiotics

Additional relevant MeSH terms:

Communicable Diseases; Infection; Keratitis; Corneal Diseases; Eye Diseases; Riboflavin; Anti-Bacterial Agents; Anti-Infective Agents; Vitamin B Complex; Vitamins; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs; Photosensitizing Agents; Dermatologic Agents