A clinical pilot study to evaluate collagen cross-linking (CXL) as a treatment for bacterial keratitis
| ISRCTN | ISRCTN21432643 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21432643 |
| Secondary identifying numbers | LV 461:2008/67089 |
- Submission date
- 30/11/2009
- Registration date
- 22/01/2010
- Last edited
- 30/10/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Karim Makdoumi
Scientific
Scientific
Department of Ophthalmology
Örebro University Hospital
Örebro
701 85
Sweden
Study information
| Study design | Prospective non-randomised clinical pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | 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 |
| Study objectives | Bacterial keratitis is a sight threatening condition with a relatively large risk for visual impairment. Bacterial strains are becoming increasingly resistant to all known antibiotics. In CXL a photo-activation of riboflavin is used, which is also used in Pathogen Inactivation Therapy in transfusion medicine. Several groups have presented treated ulcers and cases of infectious keratitis successfully treated with CXL. Based on these experiences a protocol to study CXL as a primary treatment for bacterial keratitis has been created. Hypothesis: That CXL can be used as primary therapy for bacterial keratitis. |
| Ethics approval(s) | Regional Ethical Committee in Uppsala, Sweden, approved on the 6th October 2008 (ref: 2008/250). An amendment was approved on the 5th June 2009. |
| Health condition(s) or problem(s) studied | Bacterial keratitis |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | Healing of the epithelium and arrest of corneal melting at two consecutive visits. |
| Secondary outcome measures | Any side effects and complications of treatment. |
| Overall study start date | 20/03/2009 |
| Completion date | 31/07/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 (final recruitment: 16) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 20/03/2009 |
| Date of final enrolment | 31/07/2010 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Department of Ophthalmology
Örebro
701 85
Sweden
701 85
Sweden
Sponsor information
Clinical Research Support (CRS) Centre, Örebro (Sweden)
Research organisation
Research organisation
c/o Jes Mortensen, MD
Department of Ophthalmology
Örebro University Hospital
Örebro
701 85
Sweden
"ROR" |
https://ror.org/02m62qy71 |
|---|
Funders
Funder type
Hospital/treatment centre
Örebro University Hospital (Sweden) - Ophthalmological research funds (D-number: OLL-57221)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2012 | Yes | No |
