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Trial registered on ANZCTR


Registration number
ACTRN12608000566336
Ethics application status
Approved
Date submitted
3/09/2008
Date registered
12/11/2008
Date last updated
4/02/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Myopia control lens efficacy trial
Scientific title
Investigation of the efficacy of the second generation Myopia Control Progressive Addition Lenses in the retardation of juvenile onset myopic progression in 6 to 12 year old children.
Secondary ID [1] 259954 0
none
Universal Trial Number (UTN)
Trial acronym
MCPAL2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Juvenile onset myopia 3633 0
Condition category
Condition code
Eye 3798 3798 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Custom designed Progressive Addition Lenses worn binocularly during normal waking hours and for all tasks where spectacles can and normally would be worn. There are two designs: a 1.00 D addition and the 1.50 D addition power, subjects are assigned to either of these designs or a single-vision lens control condition according to a pre-defined randomized sequence assigned on an incremental recruitment number. The study will compare the effectiveness of these two addition powers. The addition power reduces the accommodative demand of the wearer while doing near vision tasks (< 75 cm). The lens has a progressively increasing addition power starting at the distance viewing reference point and reaching the prescribed addition at approximately 14 mm below the fitting cross. The patient's regular prescription is additionally surfaced on the back surface of these lenses to correct any ocular errors of the eye. This may include Sphere and / or Cylinder corrections. Patients wear the lenses during normal waking hours and for all tasks where spectacles can be worn for a period of 24 months.
Intervention code [1] 3345 0
Prevention
Intervention code [2] 3346 0
Treatment: Devices
Comparator / control treatment
Single Vision prescription lens. These lenses are to be worn binocularly during normal waking hours and for all tasks where spectacles can and normally would be worn for a period of 24 months. They correct the wearers ocular errors of focus. This may include Sphere and or Cylinder corrections. Patients wear the lenses during normal waking hours and for all tasks where spectacles can be worn.
Control group
Dose comparison

Outcomes
Primary outcome [1] 4692 0
Refractive error (autorefraction) using one of the following machines -

1. Shin-Nippon SRW-5000
2. Shin Nippon NVision K5001
3. Grand Seiko FR5000 open-field autorefractor
Timepoint [1] 4692 0
at baseline and 6, 12, 18 & 24 months.
Primary outcome [2] 4693 0
Axial length of the eye. This will be measured using a Carl Zeiss Meditec 'IOL Master' http://www.meditec.zeiss.com/iolmaster
Timepoint [2] 4693 0
at baseline and 6, 12, 18 & 24 months
Secondary outcome [1] 8097 0
Peripheral refractive error. An open field auto-refractor will be used, the following models are acceptable - 1. Shin-Nippon SRW-5000 2. Shin Nippon NVision K5001 3. Grand Seiko FR5000 open-field autorefractor, 4. Grand Seiko WAM5500 open field autorefractor. The peripheral autorefraction will be measured at 5, 15, 25 & 35 degrees both Nasal and Temporal of the line of foveal sight. If 35 degrees is not possible due to subject eye-rotation limitations or equipment issues then 30 degrees may be substituted for 35 degrees (25 if 30 is not possible). Subjects will fixate targets while the peripheral refraction is made in order to minimize eye-movements. Either the subject can rotate the eye to targets eccentric to the primary measurement axis of the machine OR the machine may be rotated around the stationary eye (which ever technique best suits the equipment and investigators). Care should be taken when measuring eccentric positions that all instrument centration cues are located on the correct parts of the eye-image. Four readings will be taken at each eccentricity and the average Rx (produced by the instrument) will be used. Averages (if not calculated by the autorefractor) will be calculated by converting each of the 4 left and 4 right eye Sph, Cyl & Axis measures according to Mean sphere (M) and J0 / J45 components, averaging the 4 decomposed M, J0 & J45 components for each eye, prior to converting back to a Sph, Cyl & Axis for each eye.
Timepoint [1] 8097 0
at baseline and 6, 12, 18 & 24 months

Eligibility
Key inclusion criteria
1. Spherical equivalent refractive error (SER) of –0.50 to -4.50 D.
2. Astigmatism of not more than -1.50 D.
3. Anisometropia of not more than -1.50 D in spherical or cylindrical error.
4. Visual acuity with best subjective correction of 0.00 LogMAR or better.
5. Normal ocular health other than myopia.
6. No prior use of bifocal or progressive lenses in the last 12 months.
7. No rigid contact lenses or Bi-Focal contact lens experience and must be willing not to wear contact lenses.
8. In satisfactory health.
9. Willing and able to tolerate cycloplegia.
10. Informed parental consent.
Minimum age
6 Years
Maximum age
12 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Outside the age range 6 to 12 years at time of recruitment.
2. Not willing to wear spectacles continuously.
3. Not available for follow-up for at least 2 years.
4. Absence of parental consent to the random assignment of their child to one of three spectacle lens groups.
5. Any systemic condition which might affect refractive development or systemic diseases which may affect vision or refractive error.
6. Previous use of contact lens/PALs or other treatment for myopia within the last 12 months.
7. Defective binocular function.
8. Amblyopia and or manifested squint.
9. Vestibular disorders or motor imbalance.
10. Any other conditions precluding adherence to the Protocol.

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)
Advertising may be used to attract subjects to the study, or alternatively patient populations presenting naturally at the study site may be used. The study will be seeking those children & parents concerned about the development or continuing development of myopia. Ideally subjects with a demonstrated progressing myopic condition would be recruited.

The objectives of the recruitment session will be to determine if the child and family met the ocular criteria for participation, inform the family verbally about the study, provide a written information sheet and answer any questions raised.

The families will be told that if they participated then 'special' spectacles would be provided free-of-charge and that travel expenses for the child and one accompanying adult would be provided for future visits. Families will not be told the nature of the two treatments being offered and it will be emphasized that allocation to a treatment would be at random and could not be requested.

1. A non-cycloplegic refraction will be carried out and Visual Acuity (VA) (logMAR) measured with the lowest minus correction. A cover test will be carried out to exclude strabismus with the distance correction and with an addition of +1.50 D. Ophthalmoscopy and biomicroscopy will be carried out to identify any abnormal ocular condition present.

2. If the child meets the ocular selection criteria, the family will be informed and its consent will be obtained. Then the child will be allocated, according to a pre-determined random sequence, to either the Progressive Addition Lens (PAL), treatment group, or the Single Vision (SV) lens, control group.

The inclusion criteria are

1) Spherical equivalent refractive error (SER) of –0.50 to -4.50 D (measured under cycloplegia).
2) Astigmatism of not more than -1.50 D.
3) Anisometropia of not more than -1.50 D in spherical or cylindrical error.
4) Have best corrected visual acuity of at least 6/9 (20/30) in each eye.
5) Normal ocular health other than myopia.
6) No prior use of bifocal or progressive lenses in the last 12 months.
7) No RPG contact lens experience and must be willing not to wear contact lenses.
8) In satisfactory health.
9) Willing and able to tolerate cycloplegia (no previous reaction to cycloplegics).
10) Age 6 to 12 years at time of recruitment.
11) Willing to wear spectacles constantly.
12) Available for follow-up for at least 2 years.
13) Parents must understand and accept that there would be random assignment to one of three spectacle lens groups.
14) Able to obtain informed parental consent.

Allocation concealment will be used. The investigator assessing and enrolling the subjects will not know the condition to which the child will be assigned. Allocation is carried out by the central administration according to a predefined (randomized) assignment schedule applied in numerical recruitment order by the laboratory making the lenses for the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The Microsoft Excel randomization function is used as follows -

1. The function: ‘INT(RAND()*2.99)’ is used to generate random integers between 0 and 2.

2. This formula is copied into N cells where N is the number of subjects in the trial at the selected site.

3.The page is refreshed to change the seed of the RAND function until approximately equal numbers of 0, 1 & 2 are generated in the list.

4. The results are copied and pasted as values into a new spreadsheet. This becomes the master allocation table for the three conditions in the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
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 outside Australia
Country [1] 1183 0
China
State/province [1] 1183 0
Wenzhou
Country [2] 1184 0
Japan
State/province [2] 1184 0
Okayama

Funding & Sponsors
Funding source category [1] 3815 0
Commercial sector/Industry
Name [1] 3815 0
Carl Zeiss Vision
Address [1] 3815 0
19 Cooroora Crescent Lonsdale 5160, South Australia, Adelaide.
Country [1] 3815 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Carl Zeiss Vision
Address
19 Cooroora Crescent Lonsdale 5160, Adelaide. SA.
Country
Australia
Secondary sponsor category [1] 3424 0
None
Name [1] 3424 0
Address [1] 3424 0
Country [1] 3424 0
Other collaborator category [1] 505 0
University
Name [1] 505 0
Okayama University Hospital of Medicine and Dentistry
Address [1] 505 0
Okayama University
2-5-1 Shikata-cho, Okayama 700-8558
Japan
Country [1] 505 0
Japan
Other collaborator category [2] 522 0
University
Name [2] 522 0
Eye Hospital of Wenzhou Medical College
Address [2] 522 0
270 Xueyuan Road
Wenzhou
Zhejiang
325027
270 Xueyuan Road
Wenzhou
Zhejiang
325027
China, People's Republic
Country [2] 522 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6058 0
Eulji University
Ethics committee address [1] 6058 0
601-1 Shil Chong Gwan, 212 Yang Ji Dong
Su Jong Gu, Song Nam Shi
461-713 Gyonggi Province
Ethics committee country [1] 6058 0
Korea, Republic Of
Date submitted for ethics approval [1] 6058 0
Approval date [1] 6058 0
26/09/2008
Ethics approval number [1] 6058 0
EU 08-19
Ethics committee name [2] 6401 0
Eye hospital, Wenzhou Medical College
Ethics committee address [2] 6401 0
270 Xueyuan Road
Wenzhou
Zhejiang
325027
270 Xueyuan Road
Wenzhou
Zhejiang
325027
China, People's Republic
Ethics committee country [2] 6401 0
China
Date submitted for ethics approval [2] 6401 0
18/12/2008
Approval date [2] 6401 0
23/12/2008
Ethics approval number [2] 6401 0
N/A
Ethics committee name [3] 266804 0
Ethics Committee of the Okayama University
Ethics committee address [3] 266804 0
2-5-1 Shikata-cho, Okayama 700-8558
Ethics committee country [3] 266804 0
Japan
Date submitted for ethics approval [3] 266804 0
08/10/2008
Approval date [3] 266804 0
25/11/2008
Ethics approval number [3] 266804 0
622

Summary
Brief summary
To determine the effectiveness of a specially designed spectacle lens in the control of myopia progression in children.
Trial website
Trial related presentations / publications
Hasebe S, Jun J, Varnas SR., Myopia control with positively aspherized progressive addition lenses: a 2-year, multicenter, randomized, controlled trial. Invest Ophthalmol Vis Sci. 2014;55:7177–7188.
Public notes

Contacts
Principal investigator
Name 28893 0
Dr Saulius Varnas
Address 28893 0
Carl Zeiss - Business Group Vision Care,
Technology & Innovation / R&D,
26 Cooroora Crescent,
Lonsdale, SA 5160
Country 28893 0
Australia
Phone 28893 0
+618 8392 8327
Fax 28893 0
Email 28893 0
saulius.varnas@zeiss.com
Contact person for public queries
Name 12050 0
Dr Saulius Varnas
Address 12050 0
Carl Zeiss - Business Group Vision Care,
Technology & Innovation / R&D,
26 Cooroora Crescent, Lonsdale, SA 5160
Country 12050 0
Australia
Phone 12050 0
08 83928327
Fax 12050 0
08 83928400
Email 12050 0
saulius.varnas@zeiss.com
Contact person for scientific queries
Name 2978 0
Dr Saulius Varnas
Address 2978 0
Carl Zeiss - Business Group Vision Care,
Technology & Innovation / R&D,
26 Cooroora Crescent, Lonsdale, SA 5160
Country 2978 0
Australia
Phone 2978 0
08 83928327
Fax 2978 0
08 83928400
Email 2978 0
saulius.varnas@zeiss.com

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