Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000725763
Ethics application status
Approved
Date submitted
24/04/2021
Date registered
20/05/2022
Date last updated
20/05/2022
Date data sharing statement initially provided
20/05/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Home Monitoring of Age-Related Macular Degeneration
Scientific title
Home Based Monitoring of Visual Function in Age-Related Macular Degeneration - The effectiveness of eye-tracking
Secondary ID [1] 304053 0
None
Universal Trial Number (UTN)
U1111-1263-8643
Trial acronym
AMD: age-related macular degeneration
eAMD: early AMD
iAMD: intermediate AMD
nAMD: neovascular AMD
OCT: optical coherent tomography
VA and BCVA: visual acuity and best-corrected visual acuity
ET: eye-tracking
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Age-Related Macular Degeneration 321696 0
Condition category
Condition code
Eye 319434 319434 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: intermediate age-related macular degeneration (iAMD) subjects; Group 2: neovascular age-related macular degeneration (nAMD) subjects.
Each session takes approximately 40 minutes and includes the measurement of visual acuity, contrast sensitivity, optical coherent tomography (OCT), MNReading test, fixation eye-tracking task and reading eye-tracking task. Each subject receives three sessions three months apart.

A reading App on Apple iPad to track eye movement parameters. Subjects are required to read some general reading passages. The reading app is specifically designed for this study.

The location is at Tony Han Optometrists Ltd, Tauranga, New Zealand. Only the primary investigator, Tony Han, will administer the tests.
Intervention code [1] 320374 0
Early detection / Screening
Comparator / control treatment
The control group is the participants with normal eyes. The control group will undergo the same tests as the investigation group: measurement of visual acuity, contrast sensitivity, OCT, MNReading test, fixation eye-tracking task and reading eye-tracking task. (monocularly and binocularly) They are only required to attend one session, not three.
Control group
Active

Outcomes
Primary outcome [1] 327304 0
The successful detection rate of the reading app to detect the transition from intermediate AMD to neovascular AMD. This will be compared to the gold standard OCT in-clinic test.
Timepoint [1] 327304 0
Group 1: three visits in total for each subject, three months apart, complete by the end of 2022. Group 2: three visits in total for each subject, three months apart, complete by the end of 2023. Group 3: one visit for each subject, complete by the end of 2023.
Secondary outcome [1] 394520 0
Raw co-ordinate data will be recorded by the eye-trackers and saved as .csv files for comparison and analysis. The change in eye movement pattern and behaviours over time in iAMD and nAMD.
Timepoint [1] 394520 0
Post conversion to neovascular AMD.

Eligibility
Key inclusion criteria
• Age 50 years and over
• Clear ocular media
• No retinal comorbidities, such as glaucoma or any other macular diseases.
• Not taking any retinotoxic drugs
• Pass cognition test
• Group One: at least one eye has intermediate AMD; Group Two: at least one eye has neovascular AMD; Group Three: both eyes are normal.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Amblyopia
• Ocular media opacity
• No retinal comorbidities, such as glaucoma or any other macular diseases.
• Taking retinotoxic drugs
• Fail cognition test
• Unable to sign consent form
• Unable to understand English
• Unable to home test

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
n/a
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Prospective
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Tool: Matlab
Methods: ANOVA, others to be decided once receive the data sets.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/10/2021
Date of last participant enrolment
Anticipated
31/05/2023
Actual
Date of last data collection
Anticipated
30/11/2023
Actual
Sample size
Target
120
Accrual to date
40
Final
Recruitment outside Australia
Country [1] 23625 0
New Zealand
State/province [1] 23625 0
Tauranga, Auckland

Funding & Sponsors
Funding source category [1] 308437 0
University
Name [1] 308437 0
University of Auckland
Country [1] 308437 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Grafton Campus, Park Road, Grafton, Auckland 1145, NZ
Country
New Zealand
Secondary sponsor category [1] 309270 0
None
Name [1] 309270 0
Address [1] 309270 0
Country [1] 309270 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308394 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 308394 0
Ethics committee country [1] 308394 0
New Zealand
Date submitted for ethics approval [1] 308394 0
11/03/2021
Approval date [1] 308394 0
20/04/2021
Ethics approval number [1] 308394 0
21/CEN/88

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

Contacts
Principal investigator
Name 110566 0
Mr Tony Han
Address 110566 0
Tony Han Optometrists Ltd 7A Bethlehem Road Bethlehem Tauranga 3110 New Zealand
Country 110566 0
New Zealand
Phone 110566 0
+64 7 576 88 99
Fax 110566 0
+64 7 576 88 96
Email 110566 0
[email protected]
Contact person for public queries
Name 110567 0
Tony Han
Address 110567 0
Tony Han Optometrists Ltd 7A Bethlehem Road Bethlehem Tauranga 3110 New Zealand
Country 110567 0
New Zealand
Phone 110567 0
+64 7 576 88 99
Fax 110567 0
+64 7 576 88 96
Email 110567 0
[email protected]
Contact person for scientific queries
Name 110568 0
Tony Han
Address 110568 0
Tony Han Tony Han Optometrists Ltd 7A Bethlehem Road Bethlehem Tauranga 3110
Country 110568 0
New Zealand
Phone 110568 0
+64 7 576 88 99
Fax 110568 0
+64 7 576 88 96
Email 110568 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• case-by-case basis at the discretion of the Primary Sponsor, the University of Auckland.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Raw eye movement data

What types of analyses could be done with individual participant data?
• only to achieve the aims in the approved proposal

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication and no end date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• access subject to approvals by Principal Investigator
[email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11464Study protocol    Study-related document.pdf
11465Informed consent form    Study-related document.pdf
11466Ethical approval    Study-related document.pdf



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.