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Trial registered on ANZCTR


Registration number
ACTRN12611001141932
Ethics application status
Approved
Date submitted
31/10/2011
Date registered
1/11/2011
Date last updated
1/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective and open label study of children and adolescents wearing multifocal contact lenses bilaterally to assess myopia progression rates over 4 years.
Scientific title
Assessment of effect of multifocal contact lenses on myopia progression rates in children and adolescents
Secondary ID [1] 273299 0
Nill
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 279072 0
Condition category
Condition code
Eye 279260 279260 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are wearing multifocal contact lenses that correct their myopia on a daily wear basis for a minimum of 5 days a week and at least 6 hours per day over a 4 year period.
This trial is a direct follow up to trial IERP2007-009 as it was offered to those that completed IERP2007-009. The aim of this trial was to evaluate the rate of myopia progression, as assessed by cycloplegic autorefraction in children and adolescents wearing multifocal soft contact lenses over a 4-year period following participation in IERP2007-009.The main objective of IERP2007-009 was to compare the rate of myopia progression, as assessed by cycloplegic autorefraction in children wearing multifocal soft contact lenses as compared to children wearing single vision soft contact lenses over a 3-year period.
Intervention code [1] 283646 0
Treatment: Devices
Comparator / control treatment
No control being used.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279882 0
To estimate the rate of myopia progression by cycloplegic autorefraction.
Timepoint [1] 279882 0
Every 6 months for total duration of 4 years
Secondary outcome [1] 294672 0
To determine the characteristics of the peripheral refraction profile with and without multifocal contact lenses
Timepoint [1] 294672 0
Every 6 months for total duration of 4 years

Eligibility
Key inclusion criteria
-have successfully participated 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 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
11 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-pre-existing ocular irritation that would preclude contact lens fitting;
-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
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A study participant is considered enrolled when they have signed the Participant Information/Informed Consent Form.
All participants are allocated to receive the same multifocal lenses.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not randomised.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Prospective and bilateral
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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] 284133 0
Self funded/Unfunded
Name [1] 284133 0
Brien Holden Vision Institute
Address [1] 284133 0
Level 4 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country [1] 284133 0
Australia
Primary sponsor type
Individual
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] 269093 0
None
Name [1] 269093 0
Address [1] 269093 0
Country [1] 269093 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272091 0
VIHEC Human Research Ethics Committee
Ethics committee address [1] 272091 0
Level 4 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Ethics committee country [1] 272091 0
Australia
Date submitted for ethics approval [1] 272091 0
09/04/2008
Approval date [1] 272091 0
09/05/2008
Ethics approval number [1] 272091 0
8/01/2011

Summary
Brief summary
Prospective and open label study of children and adolescents wearing multifocal contact lenses bilaterally to assess myopia progression rates over 4 years
Trial website
Not applicable
Trial related presentations / publications
Nill
Public notes

Contacts
Principal investigator
Name 33333 0
Address 33333 0
Country 33333 0
Phone 33333 0
Fax 33333 0
Email 33333 0
Contact person for public queries
Name 16580 0
Fabian Conrad
Address 16580 0
Brien Holden Vision Institute, Level 5 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country 16580 0
Australia
Phone 16580 0
+612 93854351
Fax 16580 0
+612 9385 7401
Email 16580 0
f.conrad@brienholdenvision.org
Contact person for scientific queries
Name 7508 0
Fabian Conrad
Address 7508 0
Brien Holden Vision Institute, Level 5 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country 7508 0
Australia
Phone 7508 0
+612 93854351
Fax 7508 0
+612 9385 7401
Email 7508 0
f.conrad@brienholdenvision.org

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary