Safety and Efficacity of Corneal Collagen Crosslinking in Infectious Keratitis (Bacterial and Fungal ): Randomized,Controlled, Prospective Study.
Overview
- Phase
- Not Applicable
- Intervention
- antibiotic treatment
- Conditions
- Bacterial Keratitis
- Sponsor
- Nantes University Hospital
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Duration of corneal complete epithelial healing in days.
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
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.
Investigators
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.
Arms & Interventions
antibiotic treatment alone
Intervention: antibiotic treatment
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.
Intervention: Crosslinking
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.
Intervention: antibiotic treatment
Outcomes
Primary Outcomes
Duration of corneal complete epithelial healing in days.
Time Frame: 3 months
Secondary Outcomes
- Gain of visual acuity(3 months)
- Size of the corneal scar(3months)
- Corneal thinning(3 months)