Trial record 3 of 356 for:    "keratitis-ichthyosis-deafness syndrome" OR "Keratitis"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT02088970
First received: March 13, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  Purpose

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 Intervention
Bacterial Keratitis
Fungal Keratitis
Device: Crosslinking
Drug: antibiotic treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacity of Corneal Collagen Crosslinking in Infectious Keratitis (Bacterial and Fungal ): Randomized,Controlled, Prospective Study.

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Duration of corneal complete epithelial healing in days. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Size of the corneal scar [ Time Frame: 3months ] [ Designated as safety issue: No ]
    Size of the corneal scar at 3months expressed in % of the initial size of the corneal ulcer.

  • Corneal thinning [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Corneal thinning estimated by Anterior segment optical coherence tomography at 3 months, expressed in microns.

  • Gain of visual acuity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 38
Study Start Date: April 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02088970

Contacts
Contact: Isabelle Orignac, PH 02 40 08 34 05 isabelle.orignac@chu-nantes.fr

Locations
France
Orignac Not yet recruiting
Nantes, France, 44000
Contact: Isabelle Orignac, PH    02 40 08 34 05    isabelle.orignac@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02088970     History of Changes
Other Study ID Numbers: RC14_0004
Study First Received: March 13, 2014
Last Updated: March 13, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Dermatologic Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Photosensitizing Agents
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on October 23, 2014