Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000054516
Ethics application status
Approved
Date submitted
3/02/2006
Date registered
7/02/2006
Date last updated
7/02/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Myopia Progression and Orthokeratology Lens Wear
Scientific title
A randomised controlled cross-over trial to evaluate the effect of orthokeratology lens wear on the rate myopia progression in adolescents or young adults compared to standard single vision soft contact lens wear
Universal Trial Number (UTN)
Trial acronym
OMIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Progressing mild late-onset myopia 1018 0
Condition category
Condition code
Eye 1094 1094 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Orthokeratology lenses will be prescribed for overnight wear to a group of participants for a period of 9 months,. At cross-over (after 9 months), the type of lens worn will be changed between the two groups of participants and the lenses will be worn for a further 9 months period.
Intervention code [1] 881 0
Treatment: Devices
Comparator / control treatment
standard single vision frequent replacement soft contact lenses will be worn by another group of participants
Control group
Active

Outcomes
Primary outcome [1] 1460 0
The primary outcome measure is the difference in myopia progression in the orthokeratology lens wearing eyes compared with the eyes wearing single vision soft contact lenses.
Timepoint [1] 1460 0
The outcome measure will be taken at 3, 6 and 9 months after the commencement of wear for each type of contact lens.
Secondary outcome [1] 2617 0
1) To compare the accommodation response (focusing accuracy) in participants during orthokeratology lens wear compared with that during soft lens wear over periods of 9 months for each lens modality.
Timepoint [1] 2617 0
Measurement will be taken at 3, 6 and 9 months for each lens type.
Secondary outcome [2] 2618 0
2) To determine objectively the visual function in central and paracentral retinal areas with orthokeratology lenses compared with soft contact lenses.
Timepoint [2] 2618 0
Measurement will be taken at 3, 6 and 9 months for each lens type.

Eligibility
Key inclusion criteria
All participants are required to have myopic refractive error between -1.00D and -3.25D; to provide evidence of myopia progression in the past 6 months (approx. -0.5D); free of ocular disease or any contraindication to RGP lens or soft lens wear; have with the rule corneal toricity of <1.50D; have no history of current RPG lens wear and both eyes correctable to at least 6/6
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Anisometropia >1.00D, abnormal binocular vision, ocular pathology, systemic disease with ocular complications, active anterior surface disease that would preclude contact lens wear.

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 are contained in sealed envelopes held by staff of The University of Auckland Optometry Clinic not involved in the study. The participants are assigned to the one of the treatment groups by opening the next envelope in the appropriate stratum sequence
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block-randomization method will be used to stratify the participants by gender and the severity of refractive error so that the treatment groups are balanced.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
15/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 282 0
New Zealand
State/province [1] 282 0

Funding & Sponsors
Funding source category [1] 1196 0
University
Name [1] 1196 0
University of Auckland Research Fund
Country [1] 1196 0
New Zealand
Primary sponsor type
Individual
Name
Dr Helen Owens, Senior Lecturer, Department of Optometry, University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 1057 0
None
Name [1] 1057 0
Nil
Address [1] 1057 0
Country [1] 1057 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2519 0
Auckland Ethics Committee (Northern X Region)
Ethics committee address [1] 2519 0
Ethics committee country [1] 2519 0
New Zealand
Date submitted for ethics approval [1] 2519 0
Approval date [1] 2519 0
Ethics approval number [1] 2519 0

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

Contacts
Principal investigator
Name 35949 0
Address 35949 0
Country 35949 0
Phone 35949 0
Fax 35949 0
Email 35949 0
Contact person for public queries
Name 10070 0
Ms Elkie Wong
Address 10070 0
c/- Department of Optometry
University of Auckland
Private Bay 92019
Auckland 1020
Country 10070 0
New Zealand
Phone 10070 0
+64 9 3737599 ext. 86180
Fax 10070 0
+64 9 3082342
Email 10070 0
[email protected]
Contact person for scientific queries
Name 998 0
Dr Helen Owens
Address 998 0
c/- Department of Optometry
University of Auckland
Private Bay 92019
Auckland 1020
Country 998 0
New Zealand
Phone 998 0
+64 9 3737599 ext. 86075
Fax 998 0
+64 9 3082342
Email 998 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
No additional documents have been identified.