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

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ClinicalTrials.gov Identifier: NCT02088970
Recruitment Status : Terminated (Difficulties in reaching the desired number of patients and intermediate analysis leading to discontinuation of the study.)
First Posted : March 17, 2014
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Molds
Drug Information available for: Collagen

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





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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088970


Locations
France
Orignac
Nantes, France, 44000
Sponsors and Collaborators
Nantes University Hospital

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02088970     History of Changes
Other Study ID Numbers: RC14_0004
First Posted: March 17, 2014    Key Record Dates
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:
Keratitis
Communicable Diseases
Infection
Corneal Diseases
Eye Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Riboflavin
Anti-Infective Agents
Antitubercular Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents