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Difficulties in reaching the desired number of patients and intermediate analysis leading to discontinuation of the study.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| antibiotic treatment alone | Active Comparator |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of corneal complete epithelial healing in days. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Size of the corneal scar | Size of the corneal scar at 3months expressed in % of the initial size of the corneal ulcer. | 3months |
| Corneal thinning | Corneal thinning estimated by Anterior segment optical coherence tomography at 3 months, expressed in microns. |
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Inclusion Criteria:
Exclusion Criteria:
General criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orignac | Nantes | 44000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32557558 | Derived | 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. |
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|
|
| antibiotic treatment | Drug | If not the contact lens wearer -> Cocci Gram positive cocci
If contact lens wearer -> Gram negative bacillus
If corticosteroids, immunosuppression, latent evolution -> Fungus. = Fortum + vancomycin + Fungizone |
|
| 3 months |
| 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. | 3 months |
| ID | Term |
|---|---|
| D000081204 | Chromatin Immunoprecipitation Sequencing |
| ID | Term |
|---|---|
| D047369 | Chromatin Immunoprecipitation |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D059014 | High-Throughput Nucleotide Sequencing |
| D017421 | Sequence Analysis |
| D017422 | Sequence Analysis, DNA |
| D047468 | Immunoprecipitation |
| D007158 | Immunologic Techniques |
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