Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001103651
Ethics application status
Not yet submitted
Date submitted
9/09/2014
Date registered
17/10/2014
Date last updated
17/10/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of preferred retinal locus (PRL) training on Visual Acuity and Reading speed in patients with Macular Disease
Scientific title
The effects of preferred retinal locus (PRL) training on visual acuity and reading speed in patients with stable macular disease.
Secondary ID [1] 285304 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage macular disease 292998 0
Condition category
Condition code
Eye 293279 293279 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Immediate Training Group

Participants enrolled into this group will have weekly training sessions for 10 weeks where baseline and outcome measurements will be performed by the 'examiner' which will be an ophthalmic assistant.

Followed by preferred retinal locus (PRL) training by the 'trainer' who will be an orthoptist, this involves using the macular integrity assessment (MAIA) micro perimeter to assess macular function and determine a viable PRL. Once a PRL has been established training will be done using a program available on the MAIA where a biofeedback system is used to gain better use out of the PRL and improve fixation stability.

Each visit will take approximately 45min to complete.

On the first visit patients will also be randomised into the exercise or non exercise group. Participants will be given exercises which include pictures and words on a page to practice using their PRL.
Intervention code [1] 290213 0
Rehabilitation
Intervention code [2] 290338 0
Treatment: Other
Comparator / control treatment
Delayed Training Group

Patients enrolled into the delayed training program will be referred to the Royal Society for the Blind (RSB) for assessment with conventional low vision aids.

After the 10 weeks the participants will follow the same protocol as the immediate training program.

Once training has begun a second phase of randomisation will occur to establish if participants require regular stimulation of their PRL with take home exercises or if training in the clinic using the MAIA is enough to establish a viable PRL.
Control group
Active

Outcomes
Primary outcome [1] 293119 0
To determine the effects of PRL training will have on a participants vision for distance


Examiner – First Visit
- Assess best corrected visual acuity (BCVA) for distance using the early treatment of diabetic retinopathy study (ETDRS) vision chart, each eye separately and both eyes together
- Potential visual acuity (PVA) using the Markowitz PVA cards assessed at 50cm

Repeat Visits
- Assess BCVA for distance using the ETDRS vision chart, each eye separately and both eyes together

Final visit at 10 weeks
- Assess BCVA for distance using the ETDRS vision chart, each eye separately and both eyes together
- Potential visual acuity using the Markowitz PVA cards assessed at 50cm

- Follow up visit at 3 and 6 months
- Assess BCVA for distance using the ETDRS vision chart, each eye separately and both eyes together


Timepoint [1] 293119 0
Each of the baseline and outcome measurements will be performed at each visit over the 10 week time period.

Then re-measured at 3 and 6 months looking for regression and perhaps the need for "top up" training.

The outcomes will be assessed at the end of the 10 week time period looking for plateau effects.
Primary outcome [2] 293270 0
To develop a protocol for PRL training in a clinical setting
Timepoint [2] 293270 0
At the completion of the 10 week training program the results from the baseline and follow up tests will be analysed looking at those tests that are sensitive enough to show improvement or are deemed necessary in monitoring at participants PRL training outcomes. As well as looking for plateau effects to determine how many sessions are required.
Primary outcome [3] 293287 0
To look at the effects that PRL training has on a participants quality of life

the IVI questionnaire will be completed by each participant prior to training and post training.
Timepoint [3] 293287 0
A the end of the 10 weeks the questionnaires will be analysed looking for a change in their answers pre and post PRL training.
Secondary outcome [1] 310697 0
To determine if take home exercises are necessary to enhance PRL training in between visits

Exercises include pictures and words where participants have to practice reading whilst using their PRL
Timepoint [1] 310697 0
At the end of the 10 weeks the results from the MAIA will be analysed mainly fixation stability to determine if exercises in between visits have a positive impact on a patients in office PRL training.


Secondary outcome [2] 310788 0
To determine the effects PRL training will have on reading speed - please note this is a primary outcome

- Assess near vision acuity using an age appropriate reading add using the MNREAD acuity charts, each eye separately and both eyes together
- Assess reading speed measured in words per minute using MNREAD acuity charts using an age appropriate reading add, each eye separately and both eyes together

The above will be measured at all visits first, repeat, 3 months and 6 months.
Timepoint [2] 310788 0
The tests will be performed weekly for 10 weeks

The outcomes will be assessed at the end of the 10 week time period looking for plateau effects.

These will be remeasured at 3 and 6 months looking for regression and perhaps the need for "top up" training

Eligibility
Key inclusion criteria
Inclusion criteria – patients with stable macular disease not undergoing active treatment for their macular disease, those undergoing intravitreal injections as a maintenance treatment. The macular disease must be considered stable for 6 months. VA 6/18 or worse in their better eye, score of 1-3 on the global deterioration scale (GDS) from the SMMSE mini-mental exam.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria – patients with active macular disease, VA better than 6/18, score >4 on the GDS from the SMMSE mini-mental exam. Participants whose macular disease becomes active during the training will be excluded from the study and able to re-join once the disease process is stable again.

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)
Suitable participants will be referred to the clinic by ophthalmologists or from low vision services these recruiters do not have any involvement in the study. Once deemed suitable participants will read through and sign the informed consent form.

They will then complete the SMMSE exam to determine that the participant will have the cognitive abilities to complete the training and will either be included or excluded form the study based on these results.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
phase 1 of randomisation will involve being selected to the immediate training group or the delayed training group. Randomisation will be by the masked choice of a red or green counter from a closed bag by the patient. There will be an equal number of each colour. Green will be assigned to immediate training, and Red to delayed training groups.

The second phase of randomisation will involve being selected into the exercise group or non-exercise group. Participants will be given “eccentric viewing take home kits”, and will be asked to complete a series of exercises in between training sessions or the non-exercise group where participants will rely on what they learn from the training sessions held in the clinic. This will occur once training has begun and will involve both sets of participants i.e. the immediate and delayed training group. The same process of randomisation using Green and Red counters will be used.

Randomisation will be done by the participant in the presence of the 'trainer' and allocation to the groups will be concealed from the 'examiner'
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
ANCOVAs (repeated measured within and between)

We also calculated the power using G*Power version 3.1.9.2. To obtain a power of 0.95 a total of 60 participants (i.e.30 in the Immediate group, 30 in the Delayed group) will need to be recruited. If 20 in each group managed to be recruited the power is 0.8

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/10/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 289925 0
Self funded/Unfunded
Name [1] 289925 0
Country [1] 289925 0
Primary sponsor type
Other
Name
Eyemedics Opthalmologist
Address
Level 1
57 Greenhill Road
Wayville
SA
5063
Country
Australia
Secondary sponsor category [1] 288717 0
None
Name [1] 288717 0
Address [1] 288717 0
Country [1] 288717 0
Other collaborator category [1] 278165 0
University
Name [1] 278165 0
LaTrobe University
Faculty Health Sciences
School Allied Health
Department of Clinical Vision Sciences
Address [1] 278165 0
LaTrobe University
Faculty Health Sciences
School Allied Health
Department of Clinical Vision Sciences
HS2-312
Melbourne Bundoora
Victoria 3083
Country [1] 278165 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291642 0
The Royal Australian and New Zealand College of Ophthalmologists (RANZCO) Human Research Ethics Comm (EC00396)
Ethics committee address [1] 291642 0
Ethics committee country [1] 291642 0
Australia
Date submitted for ethics approval [1] 291642 0
19/08/2014
Approval date [1] 291642 0
Ethics approval number [1] 291642 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 178 178 0 0
/AnzctrAttachments/367061-SMMSE exam.pdf
Attachments [2] 179 179 0 0
/AnzctrAttachments/367061-IVI questionnaire .docx
Attachments [3] 180 180 0 0
/AnzctrAttachments/367061-Clinical Protocol_final .doc
Attachments [4] 181 181 0 0
/AnzctrAttachments/367061-Participant Information Sheet and Consent Form_Final.doc
Attachments [5] 182 182 0 0
/AnzctrAttachments/367061-Letter to Drs and RSB.doc

Contacts
Principal investigator
Name 51302 0
Dr Russell Phillips
Address 51302 0
Eyemedics
Level 1
57 Greenhill Road
Wayville
SA
5063
Country 51302 0
Australia
Phone 51302 0
+61882731600
Fax 51302 0
Email 51302 0
[email protected]
Contact person for public queries
Name 51303 0
Shandell Wishart
Address 51303 0
Eyemedics
Level 1
57 Greenhill Road
Wayville
SA
5063
Country 51303 0
Australia
Phone 51303 0
+61882731600
Fax 51303 0
Email 51303 0
[email protected]
Contact person for scientific queries
Name 51304 0
Shandell Wishart
Address 51304 0
Eyemedics
Level 1
57 Greenhill Road
Wayville
SA
5063
Country 51304 0
Australia
Phone 51304 0
+61882731600
Fax 51304 0
Email 51304 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

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