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Trial registered on ANZCTR


Registration number
ACTRN12621001522808
Ethics application status
Approved
Date submitted
8/10/2021
Date registered
9/11/2021
Date last updated
10/10/2022
Date data sharing statement initially provided
9/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect on Signal Quality using the Isometric Hand-Grip Test to maximize Vascular Flow in patients with macular disease
Scientific title
The effect on Signal Quality using the Isometric Hand-Grip Test to maximize Vascular Flow in patients with macular disease: a randomized crossover trial
Secondary ID [1] 305446 0
None
Universal Trial Number (UTN)
Trial acronym
SQUEEZE
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
General macular disease 323823 0
Condition category
Condition code
Eye 321330 321330 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions = 1) Optical Coherence Tomography Angiography (OCTA) without Isometric Hand Grip Test, and 2) OCTA with Isometric Hand grip test.

*OCTA enables in vivo, non-invasive visualisation of retinal and choroidal vascular flow.
*OCTA will be performed via the Cirrus HD-OCT v11.0.0.29946 Zeiss Cirrus Angioplex (Carl Zeiss Meditec; Jena, Germany) 6 × 6 mm en face macular cube scan protocol, by a research assistant. The research assistant is an optometrist who will be trained for use of this OCTA protocol. The scan involves the patient looking through an eyepiece and focussing on a centrally lit spot without blinking for approximately 10 seconds.

*Isometric Hand Grip Test induces transient elevations in systemic blood pressure and heart rate. This can subsequently alter retinal and choroidal vascular flow.
*Isometric Hand Grip Test will be performed using a digital hand dynamometer (Constant, Scale Manufacturer Camry; Zhongshan, China), by the patient. The test involves the patient sitting upright, elbow 90° in free space, shoulder adducated, and squeezing the dynamometer at 50% of the maximum voluntary contraction for approximately 90 seconds.

*All study patients will have a random eye selected to be the study eye.
*All study patients will be randomly allocated to one of two interventions sequences, i.e.:
A) OCTA without Isometric Hand Grip Test then OCTA with Isometric Hand Grip Test, or
B) OCTA with Isometric Hand Grip Test then OCTA without Isometric Hand Grip Test.
*The research assistant will explain the OCTA and Isometric Hand Grip Test protocol prior to use.

*For sequence A), patients will have two OCTA scans without Isometric Hand Grip Test acquired by the research assistant. Patients will then rest for two minutes.
*Patients will squeeze the dynamometer as hard as they can without undue stress or pain for up to three seconds. This will be noted as the maximum voluntary contraction. Patients will then rest for 15 seconds.
*Patients will squeeze the dynamometer at 50% maximum voluntary contraction for one minute. At one minute, the patient will continue squeezing while two OCTA scans with Isometric Hand Grip Test are acquired by the research assistant. Patients can stop squeezing after the two OCTA scans are acquired, or if they physically cannot squeeze any longer.

*For sequence B), the same protocol as outlined for sequence A) will be performed although with the two OCTA scans with Isometric Hand Grip Test first, then the two OCTA scans without Isometric Hand Grip Test second.

*Each sequence (A/B) takes approximately 10 minutes.
*The research assistant will be monitoring the protocol continuously, and advise the study patient if any alterations are required, e.g., sit upright, squeeze harder. This will ensure study participant adherence to the protocol. Non-adherence will be noted by the research assistant.
Intervention code [1] 321837 0
Diagnosis / Prognosis
Intervention code [2] 321838 0
Early detection / Screening
Comparator / control treatment
This is a crossover trial. The 'control' intervention is OCTA without Isometric Hand Grip Test, i.e., each patient will be their own control.
Control group
Active

Outcomes
Primary outcome [1] 329114 0
OCTA scan signal quality (integer out of 10)m measured using default Cirrus Angioplex Signal Strength Index.
Timepoint [1] 329114 0
Acquired during OCTA scans.
Secondary outcome [1] 401515 0
OCTA vessel density (percentage), measured using default Cirrus Angioplex Vessel Density.
Timepoint [1] 401515 0
Acquired during OCTA scans.
Secondary outcome [2] 401516 0
OCTA foveal avascular zone area (µm2), measured using default Cirrus Angioplex Foveal Avascular Zone Area.
Timepoint [2] 401516 0
Acquired during OCTA scans.
Secondary outcome [3] 402331 0
OCTA foveal avascular zone perimeter (µm), measured using default Cirrus Angioplex Foveal Avascular Zone Perimeter.
Timepoint [3] 402331 0
Acquired during OCTA scans.
Secondary outcome [4] 402332 0
OCTA foveal avascular zone circularity (unitless), measured using default Cirrus Angioplex Foveal Avascular Zone Circularity.
Timepoint [4] 402332 0
Acquired during OCTA scans.
Secondary outcome [5] 402333 0
OCTA B-scan vascular flow signal (percentage), measured using ImageJ v1.52a (National Institutes of Health; Bethesda, USA).
Timepoint [5] 402333 0
Acquired during OCTA scans.

Eligibility
Key inclusion criteria
Pre-existing patients at the Centre for Eye Health, who have an upcoming appointment in 2022 for macular disease assessment and have previously consented to be considered for research.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Patients with systemic hypertension or are pregnant.
*Patients who are currently in the process of referral for cataract surgery
*Patients who suffer from limb/joint pain or mobility issues.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
As a randomised crossover trial, all patients will be allocated to both interventions. Allocation of study patients into one of two sequences will be provided in sequentially numbered, opaque sealed envelopes which will be opened just prior to the patient’s study visit by the research assistant (data collector).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
One of the researchers (not involved in data collection or analysis) will perform computerised, simple randomisation of patients into one of the two sequences with equal blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The total sample size for the project is 27 participants, calculated from the following:

The average OCTA signal strength index of patients seen at the Centre for Eye Health (site of study) is 8.33 ± 0.87. Thus a sample size of 22 is needed to detect a difference of ±1 point in OCTA signal strength index with an alpha value of 0.05 at 80% power. Assuming a 20% drop out rate, a total sample size of 27 is required.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/01/2022
Actual
31/01/2022
Date of last participant enrolment
Anticipated
11/02/2023
Actual
Date of last data collection
Anticipated
11/02/2023
Actual
Sample size
Target
27
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20946 0
Centre for Eye Health - Kensington
Recruitment postcode(s) [1] 35762 0
2052 - Kensington

Funding & Sponsors
Funding source category [1] 309804 0
Other
Name [1] 309804 0
Centre for Eye Health
Country [1] 309804 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
The University of New South Wales, High St, Kensington NSW 2033
Country
Australia
Secondary sponsor category [1] 310836 0
None
Name [1] 310836 0
Address [1] 310836 0
Country [1] 310836 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309551 0
Human Research Ethics Committee UNSW
Ethics committee address [1] 309551 0
University of New South Wales, Sydney, NSW 2052.
Ethics committee country [1] 309551 0
Australia
Date submitted for ethics approval [1] 309551 0
09/06/2021
Approval date [1] 309551 0
29/07/2021
Ethics approval number [1] 309551 0
HC210450

Summary
Brief summary
This pilot project aims to investigate whether the quality of optical coherence tomography angiography (OCTA) scans, performed on patients with macular disease, can be improved using an in-office Isometric Hand Grip Test.

The primary research question this study seeks to address is:
*Does the signal quality of OCTA scans improve after performing the isometric hand grip test in individuals with macular disease?

The secondary research question is:
*Do parameters of OCTA images such as vessel density, vessel perfusion and foveal avascular zone area alter after performing the isometric hand grip test in individuals with macular disease?
Trial website
None
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 114558 0
Dr Lisa Nivison-Smith
Address 114558 0
Centre for Eye Health, Rupert Myers Building (M15) South Wing Barker Street, Gate 14, Kensington NSW 2052
Country 114558 0
Australia
Phone 114558 0
+61 02 8115 0791
Fax 114558 0
Email 114558 0
[email protected]
Contact person for public queries
Name 114559 0
Mr Matt Trinh
Address 114559 0
Centre for Eye Health, Rupert Myers Building (M15) South Wing Barker Street, Gate 14, Kensington NSW 2052
Country 114559 0
Australia
Phone 114559 0
+61 02 1300421960
Fax 114559 0
Email 114559 0
[email protected]
Contact person for scientific queries
Name 114560 0
Mr Matt Trinh
Address 114560 0
Centre for Eye Health, Rupert Myers Building (M15) South Wing Barker Street, Gate 14, Kensington NSW 2052
Country 114560 0
Australia
Phone 114560 0
+61 02 1300421960
Fax 114560 0
Email 114560 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant data will be de-identified and reported as aggregate results.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17320Study protocol  [email protected]



Results publications and other study-related documents

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