Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000499987
Ethics application status
Approved
Date submitted
11/05/2011
Date registered
12/05/2011
Date last updated
16/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Overnight contact lens treatment for myopia (short-sight) progression in children
Scientific title
Duplex orthokeratology (DOK) and myopia progression in children.
Secondary ID [1] 259740 0
NiL
Universal Trial Number (UTN)
U1111-1119-7694
Trial acronym
DOK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Juvenile-onset progressive myopia. 265838 0
Condition category
Condition code
Eye 259470 259470 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A duplex orthokeratology lens will be worn overnight every night for 18 months in one eye by children with progressing myopia. A duplex orthokeratology lens has a dual focus optic zone which moulds the cornea so as to correct myopia and to simultaneously produce myopic retinal defocus.
Intervention code [1] 264171 0
Treatment: Devices
Comparator / control treatment
Conventional orthokeratology lens worn overnight, every night for 18 months in the contralateral eye.
Control group
Active

Outcomes
Primary outcome [1] 262281 0
The primary outcome measure is the difference in vitreous chamber depth in the eye treated with the experimental lens compared with the eye that is wearing the conventional orthokeratology lens. To measure vitreous chamber depth we will use non-contact Optical Low-Coherence Reflectometry (Lenstar LS 900, Haag Streit, Switzerland).
Timepoint [1] 262281 0
Outcome measurements will be performed at 0/6/12/18 months
Secondary outcome [1] 273453 0
Secondary outcome measurements are magnitude of central and peripheral refractive error measured with an open field autrefractor (Shin Nippon NVision K5001).
Timepoint [1] 273453 0
Secondary outcome measurements will be performed at 0/6/12/18 month
Secondary outcome [2] 276277 0
Amplitude of accommodation will be measured with an open field autrefractor (Shin Nippon NVision K5001) while the participant is looking at a near target.
Timepoint [2] 276277 0
Measurements will be performed at 0/6/12/18 month
Secondary outcome [3] 276278 0
Contrast sensitivity will be measured using a Pelli-Robson contrast sensitivity chart.
Timepoint [3] 276278 0
Measurements will be performed at 0/6/12/18 month

Eligibility
Key inclusion criteria
Age, 10 to 14 years at entry; Gender, both; Ethnicity, not selected (any); Spherical equivalent refraction (SER) between -1.25D to -4.00D; Corneal astigmatism <1.50D; Anisometropia <1.00D; Myopia progression of at least 0.50 D in the previous year; Best corrected acuity of 6/6 or better in both eyes; Good ocular and general health. The child and their parents should be able to communicate in English.
Minimum age
10 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Active eye disease including Keratoconus; Recent rigid contact lens wear; Previous corneal surgery; Systemic disease which may influence visual acuity; Severe dry eye symptoms; Medication which could influence ocular health.

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)
The random allocations to groups will be placed in sealed envelopes. These envelopes will be kept by the optometry clinic receptionist, who is not involved in the study. After the participant is found eligible to be part of the study, the receptionist chooses an envelope according to gender and ethnicity of the participant, opens the envelope and tells the investigator the group allocation. The investigator has no access to the randomisation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Pseudo-random number generator. Children will be assigned to one of two groups (A and B) using pseudo-random permuted blocks design. We will use random block size of four or six. Assignment randomization will be stratified by two categories, gender and ethnicity (East Asian and Other, including New Zealand European, Indian and Maori/Pacifica) to ensure that the number of children, the gender and ethnicity are balanced within the groups and remain approximately equal as children are recruited. Children in Group A will wear the DOK lens in their dominant eye: children in Group B will wear the DOK lens in their non-dominant eye.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Paired-eye comparison
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 3293 0
New Zealand
State/province [1] 3293 0

Funding & Sponsors
Funding source category [1] 264619 0
University
Name [1] 264619 0
The University of Auckland, Department of Optometry and Vision Science
Country [1] 264619 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland, Department of Optometry and Vision Science
Address
85 Park Road
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 263757 0
None
Name [1] 263757 0
Address [1] 263757 0
Country [1] 263757 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260620 0
Lower South Regional Ethics Committee
Ethics committee address [1] 260620 0
Ethics committee country [1] 260620 0
New Zealand
Date submitted for ethics approval [1] 260620 0
15/02/2011
Approval date [1] 260620 0
14/03/2011
Ethics approval number [1] 260620 0
LRS/11/02/001

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

Contacts
Principal investigator
Name 32314 0
Address 32314 0
Country 32314 0
Phone 32314 0
Fax 32314 0
Email 32314 0
Contact person for public queries
Name 15561 0
Martin Loertscher
Address 15561 0
c/- Department of Optometry and Vision Science The University of Auckland
85 Park Road
Grafton
Auckland 1023
Country 15561 0
New Zealand
Phone 15561 0
+64 9 923 1352
Fax 15561 0
Email 15561 0
[email protected]
Contact person for scientific queries
Name 6489 0
John Phillips PhD
Address 6489 0
c/- Department of Optometry and Vision Science The University of Auckland
85 Park Road
Grafton
Auckland 1023
Country 6489 0
New Zealand
Phone 6489 0
+64 9 923 6073
Fax 6489 0
Email 6489 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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMultifocal orthokeratology versus conventional orthokeratology for myopia control: A paired-eye study.2021https://dx.doi.org/10.3390/jcm10030447
N.B. These documents automatically identified may not have been verified by the study sponsor.