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Trial registered on ANZCTR


Registration number
ACTRN12611001062910
Ethics application status
Approved
Date submitted
7/10/2011
Date registered
12/10/2011
Date last updated
18/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Corneal Collagen Cross-linking for Keratoconus in the Paediatric Age Group
Scientific title
An unmasked, prospective interventional cohort study to assess the efficacy and safety of corneal collagen cross-linking for keratoconus in the paediatric age group.
Secondary ID [1] 273179 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
keratoconus 278929 0
Condition category
Condition code
Eye 279110 279110 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a non-comparator trial to test the safety and efficacy of corneal collagen crosslinking in cases of progressive keratoconus in the paediatric age group. Corneal collagen-crosslinking involves the use of riboflavin (vitamin B2) and UVA (ultraviolet A) light. Riboflavin 0.1% will be applied to the cornea every 1-3 minutes for 30 minutes, then for a further 30 minutes during UVA treatment. Corneal pachymetry will be performed every 10 minutes, and if the pachymetry is below 400um, isotonic riboflavin (10mg/2mL) will replace 0.1% riboflavin. The UV-X device (IROC, Switzerland) will be used to deliver UVA at 3mW/cm2 for 30 minutes.


This is a single treatment, and participants will be followed up at intervals over a period of 10 years to assess for safety and efficacy.
Intervention code [1] 269508 0
Treatment: Surgery
Intervention code [2] 269532 0
Treatment: Devices
Intervention code [3] 269533 0
Treatment: Drugs
Comparator / control treatment
There is no comparator group in this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279750 0
Best corrected visual acuity (LogMAR and Snellen)
Timepoint [1] 279750 0
1 month, 3 months, 6 months, 12 months, and annually thereafter for 10 years following treatment
Primary outcome [2] 279751 0
Keratometry values
Timepoint [2] 279751 0
1 month, 3 months, 6 months, 12 months, and annually thereafter for 10 years following treatment
Secondary outcome [1] 294376 0
Change in endothelial cell count
Timepoint [1] 294376 0
1 month, 3 months, 6 months, 12 months, then annual thereafter for 10 years following treatment
Secondary outcome [2] 294377 0
Time to further procedure (eg. corneal graft)
Timepoint [2] 294377 0
12 months then annually thereafter for 10 years following treatment

Eligibility
Key inclusion criteria
1. Sex: Males or females

2. Age: 10 years to 15 years and 11 months

3. Progression documented by an increase of > 1.00D in the steepest keratometry value (or simK) measured by manual keratometry, automated keratometry or computerised videokeratography or where there is unambiguous documented evidence of progression (in the absence of keratometry) with the agreement of two or more corneal consultants
Minimum age
10 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Keratometry values greater than 60D and contact lens intolerant

2. Corneal pachymetry <400um (thinnest point measured by Orbscan videokeratography or Pentacam and confirmed by ultrasonic pachymetry)

3. History of previous corneal surgery

4. Presence of visually significant corneal scarring

5. Existance of other corneal pathology

6. A history of herpetic keratitis, chemical injury, delayed epithelial healing or recurrent erosion syndrome

7. Pregnancy or breast-feeding at the time of initial treatment

8. Allergy to riboflavin or dextran

9. Unable to comply with follow-up

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited from existing patients attending the Corneal Outpatients Clinic at the Hospital. Those meeting inclusion and exclusion criteria will be invited to take part in the study. This is an unmasked study with no control group, ie. allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 270002 0
Hospital
Name [1] 270002 0
Royal Victorian Eye and Ear Hospital
Country [1] 270002 0
Australia
Primary sponsor type
Hospital
Name
Royal Victorian Eye and Ear Hospital
Address
32 Gisborne St, East Melbourne, VIC 3002
Country
Australia
Secondary sponsor category [1] 268982 0
None
Name [1] 268982 0
Address [1] 268982 0
Country [1] 268982 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271963 0
Royal Victorian Eye and Ear Hospital HREC
Ethics committee address [1] 271963 0
32 Gisborne St, East Melbourne
Ethics committee country [1] 271963 0
Australia
Date submitted for ethics approval [1] 271963 0
10/10/2011
Approval date [1] 271963 0
Ethics approval number [1] 271963 0
11/1042H

Summary
Brief summary
This is a study to determine the safety and effectiveness of corneal collagen crosslinking in young persons aged 10-15 years and 11 months who have been diagnosed with progressive keratoconus. Keratoconus is a condition that causes distortion of the cornea (the clear, front window of the eye) that results in reduced vision. In the early stages, vision can be corrected with glasses or contact lenses, but in the more advanced stages a cornean transplant may be required. Collagen cross-linking is a treatment involving the use of riboflavin (vitamin B2) and ultraviolet light that has been shown to slow the progression of keratoconus in adults with a low risk of complications. We would like to study the safety and effectiveness of crosslinking in children.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33249 0
Address 33249 0
Country 33249 0
Phone 33249 0
Fax 33249 0
Email 33249 0
Contact person for public queries
Name 16496 0
Dr B Connell
Address 16496 0
Royal Victorian Eye and Ear Hospital
32 Gisborne St
East Melbourne, VIC 3002
Country 16496 0
Australia
Phone 16496 0
+61 3 9929 8666
Fax 16496 0
Email 16496 0
[email protected]
Contact person for scientific queries
Name 7424 0
Dr B Connell
Address 7424 0
Royal Victorian Eye and Ear Hospital
32 Gisborne St
East Melbourne, VIC 3002
Country 7424 0
Australia
Phone 7424 0
+61 3 9929 8666
Fax 7424 0
Email 7424 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
No additional documents have been identified.