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Trial registered on ANZCTR


Registration number
ACTRN12611000582954
Ethics application status
Approved
Date submitted
6/06/2011
Date registered
6/06/2011
Date last updated
14/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Myopia control with progressive spectacle lenses trial
Scientific title
Investigation of the efficacy of the third generation MC PAL lenses in the retardation of juvenile onset myopic progression in 7 to 12 year old children.
Secondary ID [1] 262321 0
Nil
Universal Trial Number (UTN)
Trial acronym
MCPAL3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Juvenile onset myopia 268030 0
Condition category
Condition code
Eye 268159 268159 0 0
Diseases / disorders of the eye

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, each having 1.00 D addition in the lower viewing zone and different peripheral near power profiles: one with rapid lateral rise in peripheral plus power (narrow near zone design) followed by an early drop off, and the other with a slow rise of peripheral plus power with late drop off (wide near zone design). 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 peripheral vision correction during near tasks with two different peripheral power profiles. The addition power will help reduce 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 12 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] 266712 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
Active

Outcomes
Primary outcome [1] 266903 0
Progression in sphere equivalent refractive error from cycloplegic autorefraction using the Grand Seiko WR-5100K open field auto-refractor.
Timepoint [1] 266903 0
At 6, 12, 18 & 24 months.
Secondary outcome [1] 276595 0
Progression in axial length of the eyeball. This will be measured using a Sonomed A Scan or Tomey A Scan ultrasound measuring device.
Timepoint [1] 276595 0
At 6, 12, 18 & 24 months.

Eligibility
Key inclusion criteria
1) Spherical equivalent refractive error (SER) of –1.00 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) 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 adverse reaction to cycloplegics).
10) Informed parental consent.
Minimum age
7 Years
Maximum age
12 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Any systemic condition which might affect refractive development or systemic diseases which may affect vision or refractive error.
2) Previous use of contact lens/PALs or other treatment for myopia within the last 12 months.
3) Defective binocular function.
4) Amblyopia and or manifested squint.
5) Vestibular disorders or motor imbalance.
6) Any other conditions precluding adherence to the Protocol.
7) Have best corrected visual acuity worse than 6/9 (20/30) in each eye.

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)
Subjects may be recruited through Ministry of Education approved visits to local ethnic Chinese schools accompanied by the screening of students for the eligibility and exclusion criteria. Interested families will be asked to enrol their children that have passed the screening tests into the trial by inviting them to the clinic and performing a range of additional tests covering all inclusion and exclusion criteria, such as ophthalmoscopy, biomicroscopy, tonometry and cover test. 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 one of the PAL (treatment) groups or the SV (control) group. Families will not be told the nature of the three lenses being offered and it will be emphasized that allocation to a particular lens would be at random and could not be requested.
The practitioner examining the child will not know the lens allocated. They will communicate the name of the subject, the allocated subject ID and full prescription to the unmasked investigator (UMI) who will enter the subjects name under the allocated ID and note the randomly pre-assigned lens type for the allocated Subject ID. The UMI will contact the surfacing laboratory with the job order that specifies prescription and lens type assigned.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We have generated a randomisation plan for 165 subjects randomised into blocks on the web site http://www.randomization.com.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
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 outside Australia
Country [1] 3614 0
Malaysia
State/province [1] 3614 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 267197 0
Commercial sector/Industry
Name [1] 267197 0
Carl Zeiss Vision
Address [1] 267197 0
26 Cooroora Crescent, Lonsdale 5160, Adelaide, South Australia
Country [1] 267197 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Carl Zeiss Vision
Address
26 Cooroora Crescent, Lonsdale 5160, Adelaide, South Australia
Country
Australia
Secondary sponsor category [1] 266267 0
None
Name [1] 266267 0
Address [1] 266267 0
Country [1] 266267 0
Other collaborator category [1] 252041 0
University
Name [1] 252041 0
Universiti Kebangsaan Malaysia
Address [1] 252041 0
Department of Optometry
Faculty of Allied Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur
Country [1] 252041 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269187 0
Research Ethics Committee Universiti Kebangsaan Malaysia
Ethics committee address [1] 269187 0
Medical Research & Industry Secretariat
Level 1,Clinical Block,
UKM Medical Centre,
Jalan Yaakob Latif, Bandan Tun Razak,
5600 Cheras, Kuala Lumpur, Malaysia
Ethics committee country [1] 269187 0
Malaysia
Date submitted for ethics approval [1] 269187 0
Approval date [1] 269187 0
19/04/2011
Ethics approval number [1] 269187 0
UKM 1.5.3.5/244/NN-050-2011

Summary
Brief summary
This double-masked randomised trial hopes to contribute to the overall effort in reducing the prevalence of myopia in general population or, at least, retard the progression of myopia in some children. It is designed with the following specific aims:
1) To assess the efficacy of the MC PAL 3 spectacle lenses for controlling the progression of myopia in children between the ages of 7 and 12 yrs relative to a SV control lens condition.
2) To assess the efficacy of two designs with 1.00 D addition and different peripheral near power profiles – a narrow near zone design and wide near zone design.
3) To assess the tolerance of children to wearing MC PAL 3 on a full time basis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32705 0
Dr Saulius Varnas
Address 32705 0
Carl Zeiss Vision R&D Australia
26 Cooroora Crescent Lonsdale, 5160 South Australia
Country 32705 0
Australia
Phone 32705 0
+618 8392 8327
Fax 32705 0
+618 8392 8400
Email 32705 0
Saulius.Varnas@vision.zeiss.com
Contact person for public queries
Name 15952 0
Dr Saulius Varnas
Address 15952 0
Carl Zeiss Vision R&D Australia
26 Cooroora Crescent
Lonsdale, 5160
South Australia
Country 15952 0
Australia
Phone 15952 0
+618 8392 8327
Fax 15952 0
+618 8392 8400
Email 15952 0
Saulius.Varnas@vision.zeiss.com
Contact person for scientific queries
Name 6880 0
Dr Saulius Varnas
Address 6880 0
Carl Zeiss Vision R&D Australia
26 Cooroora Crescent
Lonsdale, 5160
South Australia
Country 6880 0
Australia
Phone 6880 0
+618 8392 8327
Fax 6880 0
+618 8392 8400
Email 6880 0
Saulius.Varnas@vision.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