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
Ethics application status
Date submitted
Date registered
Date last updated
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
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

Study type
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' ( and IER2008-001 study 'Assessment of effect of multifocal contact lenses on myopia progression rates in children and adolescents' (
Intervention code [1] 285308 0
Treatment: Devices
Intervention code [2] 285473 0
Early detection / Screening
Comparator / control treatment
Not applicable
Control group

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

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
Both males and females
Can healthy volunteers participate?
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
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285666 0
Name [1] 285666 0
Brien Holden Vision Institute
Address [1] 285666 0
Level 4 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country [1] 285666 0
Primary sponsor type
Brien Holden Vision Institute
Level 4 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Secondary sponsor category [1] 284499 0
Name [1] 284499 0
Address [1] 284499 0
Country [1] 284499 0

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 287659 0
Approval date [1] 287659 0
Ethics approval number [1] 287659 0

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; ). 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; ) 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

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
Phone 17704 0
+612 93857516
Fax 17704 0
+612 93857401
Email 17704 0
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
Phone 8632 0
+612 93857516
Fax 8632 0
+612 93857401
Email 8632 0

No information has been provided regarding IPD availability
Summary results
No Results