Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000189921
Ethics application status
Approved
Date submitted
16/02/2011
Date registered
17/02/2011
Date last updated
23/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Corneal Collagen Cross-linking (CXL) as an adjunct in the treatment of Microbial Keratitis
Scientific title
In patients with microbial keratitis, is conventional treatment plus corneal collagen cross-linking (CXL) more effective than conventional treatment alone in terms of time to healing, visual results, and secondary interventions required?
Secondary ID [1] 259618 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Microbial keratitis 261176 0
Condition category
Condition code
Eye 259331 259331 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
riboflavin 0.1% indextran solution is applied to the cornea every 2 minutes for 30 minutes, and then ultraviolet A light at 365nm and 3 watts/cm2 exposure is applied for a further 30 minutes
Intervention code [1] 258051 0
Treatment: Other
Comparator / control treatment
Conventional topical antibiotic therapy, commencing with broad spectrum antibiotics such as Ofloxacin 0.3%, one drop every hour for 24 hours and then modification of dosage according to clinical response.
Control group
Active

Outcomes
Primary outcome [1] 262133 0
Time to resolution of microbial keratitis - initial daily examination using slitlamp biomicroscopy to detect healing of epithelial defect and resolution of stromal infiltrate
Timepoint [1] 262133 0
1 month
Secondary outcome [1] 273215 0
Secondary interventions (surgery)
Timepoint [1] 273215 0
1 month

Eligibility
Key inclusion criteria
presumed or confirmed microbial keratitis of moderate severity or worse
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
impending or actual corneal perforation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Trial participation offered to all eligible patients presenting to the RVEEH
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomised via random number generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
298
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258511 0
Hospital
Name [1] 258511 0
Royal Victorian Eye and Ear Hospital
Country [1] 258511 0
Australia
Primary sponsor type
Individual
Name
Dr Laurence Sullivan
Address
Royal Victorian Eye and Ear Hospital
32 Gisborne Street
East Melbourne
Vic 3002
Country
Australia
Secondary sponsor category [1] 257652 0
Other Collaborative groups
Name [1] 257652 0
Corneal Clinic
Address [1] 257652 0
Royal Victorian Eye and Ear Hospital
32 Gisborne Street
East Melbourne
Vic 3002
Country [1] 257652 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260483 0
Human Research and Ethics Committee
Ethics committee address [1] 260483 0
Royal Victorian Eye and Ear Hospital, 32 Gisborne Street, East MElbourne , 3002
Ethics committee country [1] 260483 0
Australia
Date submitted for ethics approval [1] 260483 0
01/05/2011
Approval date [1] 260483 0
16/07/2011
Ethics approval number [1] 260483 0
11/1015H

Summary
Brief summary
Microbial keratitis is a significant cause of ocular morbidity and visual loss, as well as a significant health cost to the community. Ultraviolet light is known to be microbicidal. We think it is likely that the proposed treatment will lead to quicker recovery from this serious eye infection and better visual outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32223 0
Address 32223 0
Country 32223 0
Phone 32223 0
Fax 32223 0
Email 32223 0
Contact person for public queries
Name 15470 0
Dr Laurence Sullivan
Address 15470 0
Royal Victorian Eye and Ear Hospital
32 Gisborne St
East Melbourne
Vic, 3002
Country 15470 0
Australia
Phone 15470 0
+61 (0)408544799
Fax 15470 0
Email 15470 0
[email protected]
Contact person for scientific queries
Name 6398 0
Dr Laurence Sullivan
Address 6398 0
Royal Victorian Eye and Ear Hospital
32 Gisborne St
East Melbourne
Vic, 3002
Country 6398 0
Australia
Phone 6398 0
+61 (0)408544799
Fax 6398 0
Email 6398 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCorneal collagen cross-linking for bacterial infectious keratitis.2020https://dx.doi.org/10.1002/14651858.CD013001.pub2
N.B. These documents automatically identified may not have been verified by the study sponsor.