Condition category
Eye Diseases
Date applied
30/11/2009
Date assigned
22/01/2010
Last edited
30/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Karim Makdoumi

ORCID ID

Contact details

Department of Ophthalmology
Örebro University Hospital
Örebro
701 85
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LV 461:2008/67089

Study information

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

Acronym

Study hypothesis

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

Regional Ethical Committee in Uppsala, Sweden, approved on the 6th October 2008 (ref: 2008/250). An amendment was approved on the 5th June 2009.

Study design

Prospective non-randomised clinical pilot study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Healing of the epithelium and arrest of corneal melting at two consecutive visits.

Secondary outcome measures

Any side effects and complications of treatment.

Overall trial start date

20/03/2009

Overall trial end date

31/07/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20 (final recruitment: 16)

Participant 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

Recruitment start date

20/03/2009

Recruitment end date

31/07/2010

Locations

Countries of recruitment

Sweden

Trial participating centre

Department of Ophthalmology
Örebro
701 85
Sweden

Sponsor information

Organisation

Clinical Research Support (CRS) Centre, Örebro (Sweden)

Sponsor details

c/o Jes Mortensen
MD
Department of Ophthalmology
Örebro University Hospital
Örebro
701 85
Sweden

Sponsor type

Research organisation

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Örebro University Hospital (Sweden) - Ophthalmological research funds (D-number: OLL-57221)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21874347

Publication citations

  1. Results

    Makdoumi K, Mortensen J, Sorkhabi O, Malmvall BE, Crafoord S, UVA-riboflavin photochemical therapy of bacterial keratitis: a pilot study., Graefes Arch. Clin. Exp. Ophthalmol., 2012, 250, 1, 95-102, doi: 10.1007/s00417-011-1754-1.

Additional files

Editorial Notes