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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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12 February 2013 |
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Main ID: |
ISRCTN21432643 |
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Date of registration:
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22/01/2010 |
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Primary sponsor: |
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Public title:
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A clinical pilot study to evaluate collagen cross-linking (CXL) as a treatment for bacterial keratitis
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Scientific title:
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To study the effect of collagen cross-linking (CXL) as a primary treatment for bacterial keratitis in two ophthalmological centres, through a non-randomised clinical pilot study of twenty patients |
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Date of first enrolment:
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Mar 20 2009 |
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Target sample size:
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20 (final recruitment: 16) |
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Recruitment status: |
Completed/Not recruiting |
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URL:
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http://isrctn.org/ISRCTN21432643 |
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Study type:
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Interventional |
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Study design:
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Prospective non-randomised clinical pilot study
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Karim
Makdoumi |
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Address:
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Department of Ophthalmology
Örebro University Hospital
701 85
Örebro
Sweden |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: To be included in the study all patients must fulfil the following criteria:
1. Suspected bacterial keratitis
2. Aged 18 years or above, either sex
3. Signed informed consent
Exclusion criteria: 1. Any antibiotic treatment for the current episode of keratitis
2. Suspicion of a non-bacterial keratitis
3. Pachymetry values under 400 mm
4. Pregnancy or breast-feeding
5. Allergy towards riboflavin or any substance in Ricrolin®
6. Participation in any ophthalmological study in which the follow-up is not completed
7. The patient might not be able to complete the follow-up after treatment required in the study
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Bacterial keratitis
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Intervention(s)
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Please note that as of 03/08/10 the status of this trial was changed to completed. The previously anticipated end date was 31/12/10. The decision was made to end the trial after the inclusion of 16 patients as study coordinators see this number as sufficient to answer the hypothesis.
Microbial culturing is conducted. CXL is performed with settings for keratoconus after pachymetry. Post-operatively the patient is examined one to several times daily until healing has taken place. Slit-lamp photography is done at each examination. The patient is excluded from the study if signs of infectious progress are seen and if the results from microbial culturing are negative. Healing of the keratitis at two consecutive visits is defined as the primary end-point. The patient is followed until no symptoms are present and complete healing of the ulcer has been observed.
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Primary Outcome(s)
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Healing of the epithelium and arrest of corneal melting at two consecutive visits.
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Secondary Outcome(s)
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Any side effects and complications of treatment.
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Secondary ID(s)
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LV 461:2008/67089
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Source(s) of Monetary Support
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Örebro University Hospital (Sweden) - Ophthalmological research funds (D-number: OLL-57221)
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