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

Primary Purpose

Bacterial Keratitis, Fungal Keratitis

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Crosslinking
antibiotic treatment
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Keratitis focused on measuring Infectious keratitis, Corneal cross linking, Topical antibiotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orignac

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

antibiotic treatment alone

Crosslinking + Antibiotic

Arm Description

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.

Outcomes

Primary Outcome Measures

Duration of corneal complete epithelial healing in days.

Secondary Outcome Measures

Size of the corneal scar
Size of the corneal scar at 3months expressed in % of the initial size of the corneal ulcer.
Corneal thinning
Corneal thinning estimated by Anterior segment optical coherence tomography at 3 months, expressed in microns.
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.

Full Information

First Posted
March 13, 2014
Last Updated
May 31, 2017
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02088970
Brief Title
Safety and Efficacity of Corneal Collagen Crosslinking in Infectious Keratitis (Bacterial and Fungal ): Randomized,Controlled, Prospective Study. (CXL)
Acronym
CXL
Official Title
Safety and Efficacity of Corneal Collagen Crosslinking in Infectious Keratitis (Bacterial and Fungal ): Randomized,Controlled, Prospective Study.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Difficulties in reaching the desired number of patients and intermediate analysis leading to discontinuation of the study.
Study Start Date
September 2014 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Keratitis, Fungal Keratitis
Keywords
Infectious keratitis, Corneal cross linking, Topical antibiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
antibiotic treatment alone
Arm Type
Active Comparator
Arm Title
Crosslinking + Antibiotic
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Crosslinking
Other Intervention Name(s)
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)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
antibiotic treatment
Intervention Description
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 Measure Information:
Title
Duration of corneal complete epithelial healing in days.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Size of the corneal scar
Description
Size of the corneal scar at 3months expressed in % of the initial size of the corneal ulcer.
Time Frame
3months
Title
Corneal thinning
Description
Corneal thinning estimated by Anterior segment optical coherence tomography at 3 months, expressed in microns.
Time Frame
3 months
Title
Gain of visual acuity
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Orignac
City
Nantes
ZIP/Postal Code
44000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32557558
Citation
Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.
Results Reference
derived

Learn more about this trial

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

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