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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]

None

Universal Trial Number (UTN)

Trial acronym

SQUEEZE

Linked study record

None

Health condition

Health condition(s) or problem(s) studied:

General macular disease

Condition category

Condition code

Eye

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]

Diagnosis / Prognosis

Intervention code [2]

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]

OCTA scan signal quality (integer out of 10)m measured using default Cirrus Angioplex Signal Strength Index.

Timepoint [1]

Acquired during OCTA scans.

Secondary outcome [1]

OCTA vessel density (percentage), measured using default Cirrus Angioplex Vessel Density.

Timepoint [1]

Acquired during OCTA scans.

Secondary outcome [2]

OCTA foveal avascular zone area (µm2), measured using default Cirrus Angioplex Foveal Avascular Zone Area.

Timepoint [2]

Acquired during OCTA scans.

Secondary outcome [3]

OCTA foveal avascular zone perimeter (µm), measured using default Cirrus Angioplex Foveal Avascular Zone Perimeter.

Timepoint [3]

Acquired during OCTA scans.

Secondary outcome [4]

OCTA foveal avascular zone circularity (unitless), measured using default Cirrus Angioplex Foveal Avascular Zone Circularity.

Timepoint [4]

Acquired during OCTA scans.

Secondary outcome [5]

OCTA B-scan vascular flow signal (percentage), measured using ImageJ v1.52a (National Institutes of Health; Bethesda, USA).

Timepoint [5]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Centre for Eye Health - Kensington

Recruitment postcode(s) [1]

2052 - Kensington

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Centre for Eye Health

Address [1]

Rupert Myers Building (M15) South Wing Barker Street, Gate 14, Kensington NSW 2052

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee UNSW

Ethics committee address [1]

University of New South Wales, Sydney, NSW 2052.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/06/2021

Approval date [1]

29/07/2021

Ethics approval number [1]

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

Dr Lisa Nivison-Smith

Address

Centre for Eye Health, Rupert Myers Building (M15) South Wing Barker Street, Gate 14, Kensington NSW 2052

Country

Australia

Phone

+61 02 8115 0791

Fax

[email protected]

Contact person for public queries

Name

Matt Trinh

Address

Centre for Eye Health, Rupert Myers Building (M15) South Wing Barker Street, Gate 14, Kensington NSW 2052

Country

Australia

Phone

+61 02 1300421960

Fax

[email protected]

Contact person for scientific queries

Name

Matt Trinh

Address

Centre for Eye Health, Rupert Myers Building (M15) South Wing Barker Street, Gate 14, Kensington NSW 2052

Country

Australia

Phone

+61 02 1300421960

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
17320	Study protocol			[email protected]

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.

Trial Review

Documents added manually

Documents added automatically