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Trial registered on ANZCTR


Registration number
ACTRN12611001148965
Ethics application status
Approved
Date submitted
1/11/2011
Date registered
2/11/2011
Date last updated
5/12/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
To determine the rate of refractive error change in children wearing multifocal soft contact lens as compared to those wearing single vision soft contact lenses
Scientific title
Myopia Progression in Children: Multifocal Soft Contact Lenses Versus Single Vision Soft Contact Lenses
Secondary ID [1] 273304 0
Nill
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 279076 0
Condition category
Condition code
Eye 279266 279266 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants were given either multifocal or standard single vision soft contact lenses to wear on a daily wear basis for a minimum 10 hours a day over a 3 year period. Multifocal lenses have different powers across the lens surface whereas single vision lenses only have one power.
Intervention code [1] 283652 0
Treatment: Devices
Comparator / control treatment
Control group (single vision)
Control group
Active

Outcomes
Primary outcome [1] 279887 0
To compare the rate of myopia progression, as assessed by cycloplegic auto refraction in children wearing multifocal soft contact lenses as compared to children wearing single vision soft contact lenses over a three year period.
Timepoint [1] 279887 0
Every 3 months for a total duration of 3 years.
Secondary outcome [1] 294683 0
To determine the fitting characteristics of, and ocular response to, soft contact lenses worn on a DW basis by children aged 8 to 14 years. This will be done by clinical assessments such as Slit lamp biomicroscopy. This will be used to assess the following variables and rated using the IER Grading scales.
Lens assessment
Lens wetting
Lens surface deposition
Lens fitting
Ocular redness-bulbar and limbal
Palpebral ocular redness and roughness (in conjunction with lid eversion)
Corneal and conjunctival staining (in conjunction with fluorescein and a Wratten 12 filter)
Timepoint [1] 294683 0
Every 3 months for a total duration of 3 years.

Eligibility
Key inclusion criteria
Aged 8 to 14 years

Parents / guardians must sign the subject informed consent (Appendix 1)
Cycloplegic autorefraction - sphere -0.50 D to -4.00 D, cylinder 0 to -0.75 D
Best corrected visual acuity 6/9 or better;
On examination, eyes are required to have clinical findings considered to be “normal” and which would not prevent a subject from safely wearing contact lenses. These include:
stable and distortion-free keratometric readings;
no active corneal infection, inflammation or infection of the anterior chamber of the eye or any eye disease, injury or abnormality of the cornea, conjunctiva or eyelids that would affect the wearing of contact lenses;
no previous ocular surgery;
no severe insufficiency of lacrimal secretion (dry eyes);
no evidence of corneal hypoesthesia (reduced corneal sensitivity);
no systemic disease or use of medications that may affect the eye or produce an adverse response by the wearing of contact lenses.
Minimum age
8 Years
Maximum age
14 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Binocular vision problems
strabismus
amblyopia
External ocular problems that may impact lens fit (i.e. lid ptosis, chalazia, swollen lids).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A participant is considered enrolled once successfully dispensed with study products. Allocation concealment was done by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects are randomised by the computer database
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The study was initially known as protocol number VRRP2004-008. However due to a change of sponsor from Vision CRC to Institute of Eye Research the protcol number changed to IERP2007-009. The HREC committee was notified of this change. This study was directly followed by trial ACTRN12611001141932 - Assessment of effect of multifocal contact lenses on myopia progression rates in children and adolescents. Only participants who were in trial IERP2007-009 were offered trial ACTRN12611001141932.
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] 284135 0
Self funded/Unfunded
Name [1] 284135 0
Brien Holden Vision Institute (at the time of the trial was known as Institute for Eye Research)
Address [1] 284135 0
Level 4 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country [1] 284135 0
Australia
Primary sponsor type
Individual
Name
Brien Holden Vision Institute (at the time of the trial known as Institute for Eye Research)
Address
Level 4 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country
Australia
Secondary sponsor category [1] 269095 0
None
Name [1] 269095 0
Address [1] 269095 0
Country [1] 269095 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272096 0
The South Eastern Area Health Service Research Ethics Committee
Ethics committee address [1] 272096 0
G71 East Wing
Edmund Blacket Building
Prince of Wales Hospital
Enter from Avoca St or via Edmund Blacket courtyard
Cnr High and Avoca Street Randwick 2031 NSW
Ethics committee country [1] 272096 0
Australia
Date submitted for ethics approval [1] 272096 0
03/12/2004
Approval date [1] 272096 0
05/01/2005
Ethics approval number [1] 272096 0
1/04/0342

Summary
Brief summary
A sample of 40 subjects were equally divided into the test group (multifocal) and control group (single vision). Participants wore these lenses on a daily wear basis over a 3 year period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33337 0
Address 33337 0
Country 33337 0
Phone 33337 0
Fax 33337 0
Email 33337 0
Contact person for public queries
Name 16584 0
Fabian Conrad
Address 16584 0
Level 5 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country 16584 0
Australia
Phone 16584 0
+612 93854351
Fax 16584 0
+612 9385 7401
Email 16584 0
f.conrad@brienholdenvision.org
Contact person for scientific queries
Name 7512 0
Fabian Conrad
Address 7512 0
Level 5 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country 7512 0
Australia
Phone 7512 0
+612 93854351
Fax 7512 0
+612 9385 7401
Email 7512 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