Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000020381
Ethics application status
Approved
Date submitted
14/01/2008
Date registered
16/01/2008
Date last updated
2/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
An evidence based assessment of rehabilitation strategies appropriate to persons with macular vision loss: functional outcomes and comparaitve cost analysis.
Scientific title
An evidence based assessment of rehabilitation strategies appropriate to persons with macular vision loss: functional outcomes and comparaitve cost analysis.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macular degeneration 2709 0
Vision impairment 2710 0
Macular vision loss 2711 0
Condition category
Condition code
Eye 2831 2831 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The duration of the study was 8 weeks. Each training session lasted approximately 1 hour, spaced 1 week apart for the 8 study weeks. Participants were divided into 4 study groups.
Group 1 received training in the use of magnification aids, with up to 3 sessions during the study, with a telephone call from the researcher during the weeks when there was no training. Each telephone call lasted approximately 15 minutes. Group 2 received training in eccentric viewing (a method of moving the eyes in a different direction in order to use remaining healthy retina to look at objects in the visual field), Group 3 received both magnification and eccentric viewing and Group 4 did not receive any vision rehabilitation for the duration of the study, except for a weekly telephone call from the researcher lasting approximately 15 minutes.

This part added according to your query note:
The form of training varied from weekly sessions in person to telephone contact only.
• The Magnification group received assessment and instruction in the use of magnification over three formal sessions with the researcher. For the remainder of the program these participants were telephoned on a weekly basis to discuss use of the magnifier.
• The Eccentric Viewing group received eight training sessions in eccentric viewing. Eight training sessions was chosen, as pilot-study data indicated that initially patients demonstrate an improvement with eccentric viewing but this progress stalls at session 4 or 5 (Vukicevic and Fitzmaurice, 2002) Persistence beyond this plateau results in continued improvement if eccentric viewing training continues beyond 6 sessions.
• The Combination group received both magnification and training in eccentric viewing as per group 1 and 2.
Intervention code [1] 2447 0
Rehabilitation
Comparator / control treatment
One group of participants did not have any rehabilitation intervention for the duration of the study. They did receive a weekly telephone call from the researcher and were not told that intervention was being witheld during the study.

This part added according to your query note:
The Non-intervention group was a control group that received a weekly phone call for the duration of the study, lasting up to 15 minutes per call providing support but no rehabilitation advice.
Control group
Active

Outcomes
Primary outcome [1] 3714 0
Reading parameters including:
* Near print size (tested using the Bailey-Lovie Word Reading Chart)
* Reading speed and comprehension (tested using the PAT-R reading and copmrehension test, devleoped by the Australian Council for Educational Research)
Timepoint [1] 3714 0
Baseline, 8 weeks, 6 months
Secondary outcome [1] 6264 0
Performace of activities of daily living (tested using the Melbourne Activities of Daily Living Index)
Timepoint [1] 6264 0
Baseline, 8 weeks, 6 months

Eligibility
Key inclusion criteria
• Generally healthy persons, aged 50 years and over.
• Legal blindness according to Australian Social Security classifications, which equates to a level of acuity of 6/60 or less, fully corrected in the better eye.
• A diagnosis of age-related macular degeneration, Stargardt disease or any other ocular disorder resulting in profound macular vision loss with an absolute central scotoma, present bilaterally, for which no further ophthalmological treatment was available, as determined by an ophthalmologist.
Minimum age
62 Years
Maximum age
96 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Poor general health, secondary ocular pathology affecting their visual acuity, diagnosed dementia, previous vision rehabilitation.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once recruited for the study and after informed consent had been given, participants were randomly allocated into one of four study groups, with n=12 in each group. Allocation into a study group depended upon the order in which each participant was enrolled in the study. The first participant was allocated to the Magnification group, the second into the Eccentric viewing group, the third into the Combination group and fourth into the Non-intervention group. This allocation process was then repeated with the other participants. Participants were aware that they would be allocated to a study group but not to which group they were assigned or whether intervention differed depending on group allocation. Following completion of data collection at the 6-month follow up, participants were informed of which group they had been allocated to and in the event that they had not received a particular rehabilitation intervention, were offered it outside the scope of this study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation into a study group depended upon the order in which each participant was enrolled in the study. Participants were referred and enrolled in the study over a period of 2 years. Therefore, they were allocated a number at enrollment. Patients with number 1, 5, 9 etc were placed in the magnifier group, number 2, 6,10 etc went into the eccentric viewing group and so on.
Masking / blinding
Open (masking not 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
1/07/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 547 0
3108
Recruitment postcode(s) [2] 548 0
3199
Recruitment postcode(s) [3] 549 0
3002
Recruitment postcode(s) [4] 550 0
3150

Funding & Sponsors
Funding source category [1] 2963 0
Self funded/Unfunded
Name [1] 2963 0
Country [1] 2963 0
Primary sponsor type
Individual
Name
Dr Meri Vukicevic
Address
Department of Clinical Vision Sciences
Division of Allied Health
Faculty of Health Sciences
La Trobe University Victoria 3086
Country
Australia
Secondary sponsor category [1] 2674 0
University
Name [1] 2674 0
La Trobe University
Address [1] 2674 0
Department of Clinical Vision Sciences
Division of Allied Health
Faculty of Health Sciences
La Trobe University Victoria 3086
Country [1] 2674 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4913 0
La Trobe University Faculty Health Science Ethics Committee
Ethics committee address [1] 4913 0
Ethics committee country [1] 4913 0
Australia
Date submitted for ethics approval [1] 4913 0
01/05/2003
Approval date [1] 4913 0
25/06/2003
Ethics approval number [1] 4913 0
FHEC03/080

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

Contacts
Principal investigator
Name 28296 0
Address 28296 0
Country 28296 0
Phone 28296 0
Fax 28296 0
Email 28296 0
Contact person for public queries
Name 11453 0
Dr Meri Vukicevic
Address 11453 0
Department of Clinical Vision Sciences
Division of Allied Health
Faculty of Health Sciences
La Trobe University Victoria 3086
Country 11453 0
Australia
Phone 11453 0
+61 3 9479 1807
Fax 11453 0
+61 3 9479 3692
Email 11453 0
[email protected]
Contact person for scientific queries
Name 2381 0
Dr Meri Vukicevic
Address 2381 0
Department of Clinical Vision Sciences
Division of Allied Health
Faculty of Health Sciences
La Trobe University Victoria 3086
Country 2381 0
Australia
Phone 2381 0
+61 3 9479 1807
Fax 2381 0
Email 2381 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.