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Trial registered on ANZCTR


Registration number
ACTRN12611000601932
Ethics application status
Approved
Date submitted
5/06/2011
Date registered
10/06/2011
Date last updated
17/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Corneal cross linking in the treatment of juvenile onset early keratoconus
Scientific title
A prospective comparison of corneal cross linking treatment parameters and outcomes for juvenile onset early keratoconus
Secondary ID [1] 929 0
Mater project 1841
Secondary ID [2] 280288 0
Mater HREC No 1769C
Universal Trial Number (UTN)
Trial acronym
JXL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Keratoconus 237280 0
Condition category
Condition code
Eye 239608 239608 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with juvenile onset early keratoconus will be treated with one of two treatment options to assess safety, efficacy of treatment. The 'High power short duration' (6mW/cm2 for 15 minutes) will be considered to be the 'treatment arm'. This is delivered as a single one off event delivered by Optolink(c) Ultraviolet illuminator as part of the process of corneal cross linking for keratoconus.
Intervention code [1] 236960 0
Treatment: Devices
Comparator / control treatment
The 'Low power long duration' (3mW/cm2 for 30 minutes) is the active control treatment. This is delivered as a single one off event delivered by Optolink(c) Ultraviolet illuminator as part of the process of corneal cross linking for keratoconus.

Most UV crosslinking devices only go at one speed and consequently the literature is biased towards this. The TGA approved UV device I am using is capable of equi-dosing at twice the illumination intensity and therefore half the speed.
The work of AJ Kanellopoulos looked at this faster equi-dosing intervention in his 2009 publication in adults.
These patients are all patients under my care and the treatments occurred from 22nd January 2009 until 8th April 2011. No further active treatments in this control arm are envisaged.
Control group
Historical

Outcomes
Primary outcome [1] 238394 0
Best corrected vision will be measured using a Snellen visual acuity chart and lines of vision recorded at 6 meters with the patients best correction (unaided, spectacles or contact lens) in place.
Timepoint [1] 238394 0
Preoperatively
Week 1,
week 4-6,
6 months
12 months
yr 2,3,4 and 5
Primary outcome [2] 266917 0
Unaided vision will be measured using a Snellen visual acuity chart and lines of vision recorded at 6 meters with no corrective spectacle or contact lens in place in place. If the patient is a contact lens wearer the patient will be asked to remove their contact lens from the night before the clinic appoointment.
Timepoint [2] 266917 0
Preoperatively
Week 1,
week 4-6,
6 months
12 months
yr 2,3,4 and 5
Secondary outcome [1] 244855 0
Pentacam topography Kmax value

The maximum keratometry is an instrument specific (Pentacam topographer) measurement in dioptres and represents the maximum optical power of the cornea.
Pentacam topogrpahy is a non contact measurement involving rotating light beams which produce Schiemflug images of the cornea which are reconstructed to produce various topographic profiles
Timepoint [1] 244855 0
Preoperatively
Week 1,
week 4-6,
6 months
12 months
yr 2,3,4 and 5
Secondary outcome [2] 276621 0
Pentacam thinnest pachymetry data. This is a non contact measuement derived from the pentacam topogrpaher. It locates and measure the thinnest point of the cornea
Timepoint [2] 276621 0
Preoperatively
Week 1,
week 4-6,
6 months
12 months
yr 2,3,4 and 5
Secondary outcome [3] 276622 0
Pentacam shape factor analysis is an interpolated Pentacam non contact measurement which seeks to identify both keratoconus and progression at an early (preclinical) stage.
It is generated from the interplay of the pentacam derived (1) corneal thickness spatial profile (2) Percentage thickness increase (3) Deviation parameters.
Timepoint [3] 276622 0
Preoperatively
Week 1,
week 4-6,
6 months
12 months
yr 2,3,4 and 5
Secondary outcome [4] 276623 0
Specular microscopy is a non contact instrument which records an image of the internal monolayer of cells that is the corneal endothelium. Cell density and descriptive record of the corneal endothelail mosaic are analysed. Measurement require 50-100 cell centres to be marked in the central field to allow a meaningful interpretation of the pattern and cell density.
Timepoint [4] 276623 0
Preoperatively
week 4-6,
6 months
12 months
yr 2,3,4 and 5

Eligibility
Key inclusion criteria
Early Keratoconus must be evidenced by one or more of the following Pentacam derived topographic abnormalities in the study eye

1. Corneal shape factor indicative of keratoconus on Pentacam assessment

Abnormal Enhanced Ectasia Display flags abnormalities based on regression analysis of findings compared to normality indices for
(A) Corneal thickness spatial profile (CTSP)
(B) Percentage thickness increase (PTI)
(C) Deviation parameters (D)

2. Thinnest pachymetry of less than 480microm
3. Kmax of greater than 48 D
4. Posterior corneal elevation of greater than 25 microm on Pentacam analysis

and be associated with patient reported history, topographic or refraction data which indicates one of the following changes notes in less than a 12 month period of follow up.

5. Patient reported history of visual loss in study eye during last 1 year.
6. An increase of greater than or equal to 0.75 Diopters (D) in the steepest keratometry value (Kmax on Pentacam).
7. An increase of greater than than or equal to 0.50D in regular astigmatism evaluated by manifest subjective refraction.
8. A myopic shift (decrease in the spherical equivalent) on manifest refraction of 0.50D.
9. Corneal thinning of greater than or equal to 15 microm in less then 12 months on the same pachymeter.
10. Unaided visual acuity in the study eye falling from logmar equivalent recorded level of 1.0

Patients with other keratoconus characteristics will not be entered into the trial but offered follow up on a 3-6 monthly basis and if there unaided vision falls be invited to participate at that point.
Minimum age
5 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
Eyes will not be eligible to be recruited into the trial if anyone or more of the following apply:
1. Patient age is 18 years or older
2. There is a history of previous corneal surgery.
3. Corneal pachymetry of less than 340microm (thinnest point measured by Pentacam topographer.
4. Insufficient ability to comply with full testing involved in the study
5.The presence of visually significant corneal stromal scarring.
6. The existence of other corneal pathology.
7. A history of herpetic keratitis, chemical injury, or delayed epithelial healing.
8. Recurrent corneal erosion syndrome.
9. Pregnancy or breast-feeding at the time of the initial treatment.
10. Allergy to Riboflavin.

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)
Patients presenting to clinic and judged clinically to have progressive keratoconus will be offered treatment and allocated to the 6mW/cm2 for 15 minutes arm of the trial only. All patients treated previously by either 3mW/cm2 for 30 minutes or 6mW/cm2 for 15 minutes will be asked for their consent retrospectively for trial participation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to the 3mW/cm2 was historical active control.
Allocation to the 6mW/cm2 is the only current intervention option to be offered
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The slower intervention group (active controls) were treated first and no further recruitment to this group will occur. Data collected prospectively in the course of the active control group as part of clinical care will used once their consent has been obtained retrospectively for them to participate. All further recruitment will be to the faster intervention arm of the proposed study.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/09/2011
Actual
5/12/2011
Date of last participant enrolment
Anticipated
12/12/2013
Actual
5/12/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
102
Accrual to date
Final
102
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237345 0
Hospital
Name [1] 237345 0
Mater Public Hospital
Country [1] 237345 0
Australia
Primary sponsor type
Individual
Name
Dr James MC Alister
Address
Department of Ophthalmology
Raymond Terrace
Brisbane
Queensland 4101
Country
Australia
Secondary sponsor category [1] 236836 0
None
Name [1] 236836 0
Address [1] 236836 0
Country [1] 236836 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239465 0
Mater Human research and ethics committee
Ethics committee address [1] 239465 0
Ethics committee country [1] 239465 0
Australia
Date submitted for ethics approval [1] 239465 0
11/06/2011
Approval date [1] 239465 0
07/11/2011
Ethics approval number [1] 239465 0
Mater Project 1841

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29916 0
Dr James Charles McAlister
Address 29916 0
Eyesmatter Clinic
144 Edward Street
Brisbane, Q4000
Queensland
Country 29916 0
Australia
Phone 29916 0
+617-3193-1100
Fax 29916 0
+617-3193-1101
Email 29916 0
admin@eyesmatter.com.au
Contact person for public queries
Name 13163 0
Dr James Mc Alister
Address 13163 0
Mater Public Hospital
Eye Department
Raymond Terrace
Country 13163 0
Australia
Phone 13163 0
+617-3363-8912
Fax 13163 0
+617-3420-0189
Email 13163 0
jim.mcalister@mater.org.au
Contact person for scientific queries
Name 4091 0
Dr James Mc Alister
Address 4091 0
Mater Public Hospital
Eye Department
Raymond Terrace
Country 4091 0
Australia
Phone 4091 0
+617-3363-8912
Fax 4091 0
+61734200189
Email 4091 0
jim.mcalister@mater.org.au

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.