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Trial registered on ANZCTR


Registration number
ACTRN12612000105842
Ethics application status
Not yet submitted
Date submitted
17/01/2012
Date registered
23/01/2012
Date last updated
23/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Follow-up study on participants who participated in Institute for Eye Research Protocol (IERP2007-009) - ‘Myopia progression in children: multifocal soft contact lenses versus single vision soft contact lenses’
Scientific title
Follow-up study on participants who previously participated in IERP2007-009 ("Myopia progression in children: multifocal soft contact lenses versus single vision soft contact lenses") to determine their current ocular refractive status and collect questionnaire data.
Secondary ID [1] 279745 0
IERP2007-009 was registered with ANZCTR. Registration number: ACTRN12611001148965
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cycloplegic refraction and ocular axial length. 285603 0
Myopia 285622 0
Condition category
Condition code
Eye 285797 285797 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cycloplegic refractive error will be measured both objectively and subjectively; ocular axial length will be measured using a Zeiss IOL master. Cycloplegia will be achieved using diagnostic eye drops (1% tropicamide and 0.4% oxybuprocaine).
Intervention code [1] 284055 0
Not applicable
Comparator / control treatment
Not applicable as study is observational
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286306 0
To evaluate the rate of myopia progression, as assessed by cycloplegic autorefraction, in children and adolescents who participated in IERP2007-009.
Timepoint [1] 286306 0
This study involves only 1 visit
Primary outcome [2] 286326 0
To determine the characteristics of the peripheral refraction profiles in children and adolescents following participation in IERP2007-009. Peripheral refraction will be measured using a Shin Nippon open-field autorefractor or eyemapper instrument.
Timepoint [2] 286326 0
This study involves only 1 visit
Secondary outcome [1] 295575 0
To obtain a history of the refractive correction chosen by the participants since they completed IERP2007-009 and their lifestyle variables. This outcome will be assessed using questionnaires.
Timepoint [1] 295575 0
This study involves only 1 visit

Eligibility
Key inclusion criteria
have successfully enrolled in study IERP2007-009
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, be accompanied by their parent(s)/legal guardian when signing the informed consent form;
be willing to comply with the clinical trial visit schedule as directed by the investigator;
have ocular health findings considered to be “normal”;
Minimum age
15 Years
Maximum age
21 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude the use of diagnostic eye drops (1% tropicamide and 0.4% oxybuprocaine).
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;
had eye surgery within 12 weeks immediately prior to enrolment for this trial;
known allergy or intolerance to ingredients in any of the clinical trial products

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 284526 0
Charities/Societies/Foundations
Name [1] 284526 0
Brien Holden Vision Institute
Address [1] 284526 0
Level 4 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country [1] 284526 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] 283455 0
None
Name [1] 283455 0
Address [1] 283455 0
Country [1] 283455 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286511 0
Bellberry Limited
Ethics committee address [1] 286511 0
229 Greenhill Road, Dulwich, South Australia, 5065
Ethics committee country [1] 286511 0
Australia
Date submitted for ethics approval [1] 286511 0
11/01/2012
Approval date [1] 286511 0
Ethics approval number [1] 286511 0

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). 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. 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).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33643 0
Address 33643 0
Country 33643 0
Phone 33643 0
Fax 33643 0
Email 33643 0
Contact person for public queries
Name 16890 0
Fabian Conrad
Address 16890 0
Level 5 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country 16890 0
Australia
Phone 16890 0
+612 93857516
Fax 16890 0
+612 93857401
Email 16890 0
f.conrad@brienholdenvision.org
Contact person for scientific queries
Name 7818 0
Fabian Conrad
Address 7818 0
Level 5 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country 7818 0
Australia
Phone 7818 0
+612 93857516
Fax 7818 0
Email 7818 0
f.conrad@brienholdenvision.org

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