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Trial registered on ANZCTR


Registration number
ACTRN12605000633684
Ethics application status
Approved
Date submitted
10/10/2005
Date registered
13/10/2005
Date last updated
25/07/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial of an experimental soft contact lens designed to inhibit the progression of axial myopia in children.
Scientific title
Trial of an experimental frequent-replacement soft contact lens designed to correct vision and simultaneously produce myopic retinal defocus during distance and near vision in order to inhibit axial elongation of the eye and myopia progression in children.
Universal Trial Number (UTN)
Trial acronym
DIMENZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Progressing juvenile-onset myopia. 761 0
Condition category
Condition code
Eye 837 837 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A frequent replacement soft contact lens that both corrects vision and simultaneously produces myopic retinal defocus will be worn monocularly for 10 months by children with progressing myopia. The fellow eye will be corrected with a standard single vision frequent replacement soft contact lens. At cross-over (after 10 months) the identity of the eyes wearing the experimental and the single vision lenses will be reversed and the lenses will be worn for a further 10 months.
Intervention code [1] 705 0
Treatment: Devices
Comparator / control treatment
Single vision contact lenses
Control group
Active

Outcomes
Primary outcome [1] 1074 0
The primary outcome measure is the difference in axial myopia progression rate in the eye corrected with the experimental lens compared with the that in the eye wearing the single vision lens.
Timepoint [1] 1074 0
Outcome measures will be made at 5 and 10 months. The experimental lens will then be crossed over to the contralateral eye and further outcome measures will be made at 15 and 20 months.
Primary outcome [2] 1075 0
To measure changes in axial myopia it is necessary to measure both changes in refractive error (with cycloplegic autorefraction) and changes in the axial length of the eye (with partial coherence interferometry) in both eyes.
Timepoint [2] 1075 0
Outcome measures will be made at 5 and 10 months. The experimental lens will then be crossed over to the contralateral eye and further outcome measures will be made at 15 and 20 months.
Secondary outcome [1] 1994 0
1. To determine the accommodative status of the participants while wearing the experimental contact lens.
Timepoint [1] 1994 0
Measurements of accommodative response will be recorded one week after contact lens fitting with the treatment lens, and at 5, 10, 15 and 20 months.
Secondary outcome [2] 1995 0
2. To assess visual function while wearing the experimental contact lens design.
Timepoint [2] 1995 0
Measurements of visual acuity, contrast senstivity and binocular vision will be recorded at baseline, 10 and 20 months.

Eligibility
Key inclusion criteria
Progressing myopia, spherical equivalent refraction of -1.50 to -4.00, visual acuity of 6/6 or better, ability to independently handle contact lenses, prepared to wear contact lenses full-time for the duration of the study.
Minimum age
11 Years
Maximum age
14 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Astigmatism > 0.75D, anisometropia > 1.00D, abnormal binocular vision, ocular pathology, systemic disease with ocular complications, active anterior surface disease that would preclude contact lens wear, inadequate fit of soft contact lenses.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomly generated allocations (see sequence generation below) are contained in opaque sealed envelopes held by staff of The Univeristy of Auckland Optometry Clinic not involved in the study. As participants are recruited, the next envelope in the appropriate stratum sequence is opened and the participant assigned to the stated treatment group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects are stratified (4 strata) according to the prognostic factors of gender (male and female) and ethnicity (Asian and non-Asian) using a computer generated block-randomization programme (Clinstat, St George's Hospital Medical School, www.sgul.ac.uk/depts/phs/staff/jmb/jmbsoft.htm). Each stratum has 40 random allocations of the two treatment options (1 = experimental contact lens in the dominant eye, 2 = experimental contact lens in the non-dominant eye).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not 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 outside Australia
Country [1] 241 0
New Zealand
State/province [1] 241 0

Funding & Sponsors
Funding source category [1] 925 0
Charities/Societies/Foundations
Name [1] 925 0
Maurice and Phyllis Paykel Trust
Address [1] 925 0
PO Box 37760
Parnell
Auckland
Country [1] 925 0
New Zealand
Funding source category [2] 2651 0
Charities/Societies/Foundations
Name [2] 2651 0
NZOVRF
Address [2] 2651 0
PO Box 6283
Christchurch
Country [2] 2651 0
New Zealand
Primary sponsor type
Individual
Name
Dr John Phillips, Senior Lecturer, Department of Optometry, University of Auckland
Address
c/- Department of Optometry
The University of Auckland
Private Bag 92019
Country
New Zealand
Secondary sponsor category [1] 783 0
None
Name [1] 783 0
Not applicable
Address [1] 783 0
Country [1] 783 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2218 0
Northern X Regional Ethics Committee
Ethics committee address [1] 2218 0
3rd floor, Unisys building
650 Great South Rd
Penrose
Private Bag 92-522, Wellesley St
Auckland
Ethics committee country [1] 2218 0
New Zealand
Date submitted for ethics approval [1] 2218 0
Approval date [1] 2218 0
Ethics approval number [1] 2218 0
NTX05/05/047

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35720 0
Address 35720 0
Country 35720 0
Phone 35720 0
Fax 35720 0
Email 35720 0
Contact person for public queries
Name 9894 0
Nicola Anstice
Address 9894 0
c/- Department of Optometry
University of Auckland
Private Bay 92019
Auckland 1020
Country 9894 0
New Zealand
Phone 9894 0
+64 9 3737599 ext. 82956
Fax 9894 0
+64 9 3082342
Email 9894 0
nanstice@xtra.co.nz
Contact person for scientific queries
Name 822 0
Dr John Phillips
Address 822 0
/- Department of Optometry
University of Auckland
Private Bay 92019
Auckland 1020
Country 822 0
New Zealand
Phone 822 0
+64 9 3737599 ext. 86073
Fax 822 0
+64 9 3082342
Email 822 0
j.phillips@auckland.ac.nz

No information has been provided regarding IPD availability
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