Trial Review

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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
Sex
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
20/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
26
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
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
[email protected]
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
[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
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Documents added automatically
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