Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000849897
Ethics application status
Approved
Date submitted
10/08/2012
Date registered
13/08/2012
Date last updated
20/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of myopia progression rates in children and adolescents
Scientific title
Prospective and open label study of children and adolescents wearing multifocal contact lenses bilaterally to assess myopia progression rates over a 7 year period.
Secondary ID [1] 280873 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 286944 0
Cycloplegic refraction 287148 0
Ocular axial length 287149 0
Condition category
Condition code
Eye 287280 287280 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cycloplegic refractive error will be measured both objectively (using Nidek Tonoref 2) and subjectively(using phoropter, subjective measure will be based on the participant's input and clinician's judgement); ocular axial length will be measured using a Zeiss IOL master (3 readings per eye will be taken, the average of these reading will be recorded, the entire procedure will take less than 5 minutes). Cycloplegia will be achieved using diagnostic eye drops (1% tropicamide and 0.4% oxybuprocaine). All participants in this study need to have completed the IERP2007-009 study 'Myopia Progression in Children: Multifocal Soft Contact Lenses Versus Single Vision Soft Contact Lenses' (http://www.anzctr.org.au/trial_view.aspx?ID=347659) and IER2008-001 study 'Assessment of effect of multifocal contact lenses on myopia progression rates in children and adolescents' (http://www.anzctr.org.au/trial_view.aspx?ID=347655)
Intervention code [1] 285308 0
Treatment: Devices
Intervention code [2] 285473 0
Early detection / Screening
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287557 0
To monitor the rate of progression of myopia, as assessed by cycloplegic auto-refraction (using Nidek TONOREF 2) and axial length change (using Zeiss IOL master)
Timepoint [1] 287557 0
At baseline, 6 month, 12month, 18month, 24month, 30month and 36month
Secondary outcome [1] 298387 0
To determine the characteristics of the peripheral refraction profiles (using Shin Nippon N-Vision K5001 Autorefractor and EyeMapper)over time in children & adolescents with and without multifocal contact lenses
Timepoint [1] 298387 0
At baseline, 12month, 24month and 36month

Eligibility
Key inclusion criteria
have successfully completed IER2008-001
be able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent (or their parent(s)/legal guardian);
if under 18 years of age, must be accompanied by their parent(s)/legal guardian when signing the informed consent form;
be willing to comply with the wearing and clinical trial visit schedule as directed by the investigator;
have ocular health findings considered to be “normal” and which would not prevent the participant from safely wearing contact lenses;
have vision correctable to at least 6/9 (20/30) or better in each eye with contact lenses;
Minimum age
15 Years
Maximum age
23 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
an ocular condition that may preclude safe wearing of contact lenses;
an active corneal infection or any active ocular disease that would affect wearing of contact lenses;
a need for concurrent category S3 and above ocular medication up to 12 weeks prior to and during the trial;
any systemic disease that may affect ocular health. Conditions such as systemic hypertension do not automatically exclude prospective participants;
any systemic or topical medications up to 12 weeks prior to and during the trial that will affect ocular physiology or the performance of the lenses;
had eye surgery within 12 weeks immediately prior to enrolment for this trial;
undergone corneal refractive surgery;
any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would affect the wearing of contact lenses;
contraindications to contact lens wear;
had orthokeratology;
binocular vision problems such as strabismus or amblyopia;
any participant from anti myopia studies who has any unresolved ocular problem
currently enrolled in another clinical trial

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A participant is enrolled when they have signed the Participant Information / Informed Consent Form. A participant is considered “successfully enrolled” when the Investigator agrees that they conform to the inclusion/ exclusion criteria, and on successful fit of clinical trial products.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/08/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285666 0
Charities/Societies/Foundations
Name [1] 285666 0
Brien Holden Vision Institute
Country [1] 285666 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Brien Holden Vision Institute
Address
Level 4 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country
Australia
Secondary sponsor category [1] 284499 0
None
Name [1] 284499 0
Address [1] 284499 0
Country [1] 284499 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287659 0
Bellberry Limited
Ethics committee address [1] 287659 0
229 Greenhill Road, Dulwich, South Australia, 5065
Ethics committee country [1] 287659 0
Australia
Date submitted for ethics approval [1] 287659 0
10/07/2012
Approval date [1] 287659 0
Ethics approval number [1] 287659 0
2012-07-930

Summary
Brief summary
The Brien Holden Vision Institute (previously known as the Institute for Eye Research) conducted a clinical trial to test commercially-available multifocal contact lenses for their potential to control the progression of myopia in children(IERP2007-009, ACTRN12611001148965; http://www.anzctr.org.au/trial_view.aspx?ID=347659 ). The trial was completed in 2008. Approximately half of the 40 children who participated in trial IERP2007-009 were enrolled in a subsequent myopia control trial at the Brien Holden Vision Institute (IER2008-001, ACTRN12611001141932; http://www.anzctr.org.au/trial_view.aspx?ID=347655 ) in which all participants wore the test product of trial IERP2007-009. Both IERP 2007-009 and IER2008-001 have provided valuable information on the efficacy of the multifocal contact lenses in controlling the rate of progression of myopia. This research is based on the hypothesis that the peripheral retina plays a role in controlling the refractive development of the eye as shown in animal experiments (Smith et al. 2007). In this study, the participants will continue to wear the commercially available multifocal contact lenses used in the previous two trials (IERP2007-009 and IER2008-001) to see whether the efficacy of controlling myopia with this lenses will still remain true for a longer period of time.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34457 0
Address 34457 0
Country 34457 0
Phone 34457 0
Fax 34457 0
Email 34457 0
Contact person for public queries
Name 17704 0
Fabian Conrad
Address 17704 0
Level 5 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country 17704 0
Australia
Phone 17704 0
+612 93857516
Fax 17704 0
+612 93857401
Email 17704 0
[email protected]
Contact person for scientific queries
Name 8632 0
Fabian Conrad
Address 8632 0
Level 5 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country 8632 0
Australia
Phone 8632 0
+612 93857516
Fax 8632 0
+612 93857401
Email 8632 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
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