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
ACTRN12613000143729
Ethics application status
Approved
Date submitted
4/02/2013
Date registered
6/02/2013
Date last updated
19/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised, Clinical Trial of Corneal Collagen Cross-Linking in Keratoconus
Scientific title
A Prospective, Randomised, Clinical Trial of Corneal Collagen Cross-Linking in Keratoconus to determine the change in the maximum simulated keratometry value on corneal topography over 5 years.
Secondary ID [1] 281884 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
keratoconus 288277 0
Condition category
Condition code
Eye 288628 288628 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
corneal collagen cross-linking. Cross-linking is a single treatment involving the use of riboflavin and UVA light to increase the strength of the cornea. The cornea is treated with riboflavin drops for 30 minutes followed by exposure to UVA irradiation for a 30 minutes, during which the riboflavin drops are continued.
Intervention code [1] 286448 0
Treatment: Surgery
Comparator / control treatment
no treatment
Control group
Active

Outcomes
Primary outcome [1] 288779 0
maximum simulated keratometry value measured using computerised videokeratography (Orbscan II; Bausch and Lomb Surgical, Utah. Patients recruited after November 2007 were also imaged with Scheimplug imaging (Pentacam HR, Oculus, Germany)
Timepoint [1] 288779 0
5 years
Secondary outcome [1] 300982 0
uncorrected visual acuity expressed as logarithm of the minimum angle of resolution (logMAR)
Timepoint [1] 300982 0
5 years
Secondary outcome [2] 300983 0
best-spectacle corrected visual acuity expressed as logarithm of the minimum angle of resolution (logMAR)
Timepoint [2] 300983 0
5 years
Secondary outcome [3] 300984 0
subjective refraction (sphere and cylinder) performed by trained orthoptists
Timepoint [3] 300984 0
5 years
Secondary outcome [4] 300985 0
minimum simulated keratometry value measured using computerised videokeratography (Orbscan II; Bausch and Lomb Surgical, Utah). Patients recruited after November 2007 were also imaged with Scheimplug imaging (Pentacam HR, Oculus, Germany)
Timepoint [4] 300985 0
5 years
Secondary outcome [5] 300986 0
corneal thickness at the thinnest point using ultrasound pachymetry (Pachy Meter SP3000; Tomey, Nagoya, Japan), computerised videokeratography (Orbscan II; Bausch and Lomb Surgical, Utah) and Scheimplug imaging (Pentacam HR, Oculus, Germany)
Timepoint [5] 300986 0
5 years
Secondary outcome [6] 300987 0
endothelial cell density using the SP 2000 Specular Microscope (Topcon Corp, Tokyo, Japan)
Timepoint [6] 300987 0
5 years
Secondary outcome [7] 300988 0
intraocular pressure using the Tonopen XL (Medtronic, Jacksonville, Florida) and Goldmann applanation tonometer (Haag Streit, Konitz, Switzerland)
Timepoint [7] 300988 0
5 years

Eligibility
Key inclusion criteria
At least one of the following criteria met over the preceding 12 months: an increase of at least 1 diopter in the steepest simulated keratometry reading derived from computerized videokeratography or in the steepest meridian measured by manual keratometry; an increase in astigmatism as determined by manifest subjective refraction of at least 1 diopter; or a 0.1mm or more decrease in back optic-zone radius of the best fitting contact lens
Minimum age
16 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Minimum corneal thickness less than 400 microns; axial corneal scarring, previous refractive or other corneal surgery; a history of chemical burns; severe infections or other corneal or ocular surface disorders; patients who were pregnant or breastfeeding at the time of enrolment

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)
Patients meeting the inclusion criteria were recruited from the Cornea Clinic at the Hospital. Allocation to the treatment or control group was done using a computer generated randomization plan that was held off-site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation sequence used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
19/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
11/06/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 530 0
The Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment postcode(s) [1] 6270 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 286669 0
Hospital
Name [1] 286669 0
Royal Victorian Eye and Ear Hospital
Country [1] 286669 0
Australia
Funding source category [2] 286670 0
University
Name [2] 286670 0
Eye Research Australia Foundation, Centre for Eye Research Australia, University of Melbourne
Country [2] 286670 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] 285445 0
University
Name [1] 285445 0
Centre for Eye Research Australia, University of Melbourne
Address [1] 285445 0
32 Gisborne St, East Melbourne, VIC 3002
Country [1] 285445 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288738 0
Royal Victorian Eye and Ear Hospital Human Research and Ethics Committee
Ethics committee address [1] 288738 0
32 Gisborne St, East Melbourne, VIC 3002
Ethics committee country [1] 288738 0
Australia
Date submitted for ethics approval [1] 288738 0
Approval date [1] 288738 0
03/04/2006
Ethics approval number [1] 288738 0
05/632H

Summary
Brief summary
The technique of collagen cross-linking for keratoconus (a condition leading to thinning and protrusion of the cornea, the front clear window of the eye, leading to a reduction in vision) was introduced in Europe. It involves the use of riboflavin (vitamin B2) and ultraviolet light A, and has been shown in animal studies to strengthen the cornea. This trial was initiated to assess the effectiveness and safety of this treatment in comparison to a second group of participants who have the disease but are not given the cross-linking treatment. It runs over 5 years.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37578 0
A/Prof Grant Snibson
Address 37578 0
Royal Victorian Eye and Ear Hospital, 32 Gisborne St, East Melbourne, VIC 3002
Country 37578 0
Australia
Phone 37578 0
+61 3 9416 0695
Fax 37578 0
Email 37578 0
[email protected]
Contact person for public queries
Name 37579 0
Ms Kiera Young
Address 37579 0
Centre for Eye Research Australia, 32 Gisborne St, East Melbourne, VIC 3002
Country 37579 0
Australia
Phone 37579 0
+61 3 9929 8360
Fax 37579 0
Email 37579 0
[email protected]
Contact person for scientific queries
Name 37580 0
A/Prof Grant Snibson
Address 37580 0
Royal Victorian Eye and Ear Hospital, 32 Gisborne St, East Melbourne, VIC 3002
Country 37580 0
Australia
Phone 37580 0
+61 3 9416 0695
Fax 37580 0
Email 37580 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.