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

NCT02088970 | Terminated DMC

• 1 other identifier: RC14_0004
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Keratitis; Fungal Keratitis

Keywords

Infectious keratitis; Corneal cross linking; Topical antibiotics

Outcome Measures

Primary Outcomes (1)

• Duration of corneal complete epithelial healing in days.

  3 months

Secondary Outcomes (3)

• Size of the corneal scar

  3months

• Corneal thinning

  3 months

• Gain of visual acuity

  3 months

Study Arms (2)

antibiotic treatment alone

ACTIVE COMPARATOR

Drug: antibiotic treatment

Crosslinking + Antibiotic

EXPERIMENTAL

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; Drug: antibiotic treatment

Interventions

Crosslinking DEVICE

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.

Also known as: 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)

Crosslinking + Antibiotic

antibiotic treatment DRUG

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

Crosslinking + Antibiotic; antibiotic treatment alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Orignac

Nantes, 44000, France

Location

Related Publications (1)

• 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.

  PMID: 32557558 DERIVED

MeSH Terms

Interventions

Chromatin Immunoprecipitation Sequencing

Intervention Hierarchy (Ancestors)

Chromatin Immunoprecipitation; Genetic Techniques; Investigative Techniques; High-Throughput Nucleotide Sequencing; Sequence Analysis; Sequence Analysis, DNA; Immunoprecipitation; Immunologic Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 17, 2014
• Study Start: September 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: June 1, 2017

Record last verified: 2017-05

Locations

FR (1)