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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02088970
Acronym
CXL
Enrollment
21
Registered
2014-03-17
Start date
2014-09-30
Completion date
2017-04-30
Last updated
2017-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Keratitis, Fungal Keratitis

Keywords

Infectious keratitis, Corneal cross linking, Topical antibiotics

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.

Interventions

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.

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

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Duration of corneal complete epithelial healing in days.3 months

Secondary

MeasureTime frameDescription
Size of the corneal scar3monthsSize of the corneal scar at 3months expressed in % of the initial size of the corneal ulcer.
Corneal thinning3 monthsCorneal thinning estimated by Anterior segment optical coherence tomography at 3 months, expressed in microns.
Gain of visual acuity3 monthsGain 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026