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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

Tracking Information
First Submitted Date  ICMJE March 13, 2014
First Posted Date  ICMJE March 17, 2014
Last Update Posted Date June 1, 2017
Study Start Date  ICMJE September 2014
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
Duration of corneal complete epithelial healing in days. [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
  • 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.
  • Corneal thinning [ Time Frame: 3 months ]
    Corneal thinning estimated by Anterior segment optical coherence tomography at 3 months, expressed in microns.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacity of Corneal Collagen Crosslinking in Infectious Keratitis (Bacterial and Fungal ): Randomized,Controlled, Prospective Study. (CXL)
Official Title  ICMJE Safety and Efficacity of Corneal Collagen Crosslinking in Infectious Keratitis (Bacterial and Fungal ): Randomized,Controlled, Prospective Study.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bacterial Keratitis
  • Fungal Keratitis
Intervention  ICMJE
  • 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

Study Arms  ICMJE
  • Active Comparator: antibiotic treatment alone
    Intervention: Drug: antibiotic treatment
  • 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.

    Interventions:
    • Device: Crosslinking
    • Drug: antibiotic treatment
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 31, 2017)
21
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2014)
38
Actual Study Completion Date  ICMJE April 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02088970
Other Study ID Numbers  ICMJE RC14_0004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nantes University Hospital
Study Sponsor  ICMJE Nantes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nantes University Hospital
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP