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The effect on Signal Quality using the Isometric Hand-Grip Test to maximize Vascular Flow in patients with macular disease

The effect on Signal Quality using the Isometric Hand-Grip Test to maximize Vascular Flow in patients with macular disease: a randomized crossover trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001522808
Acronym
SQUEEZE
Enrollment
25
Registered
2021-11-09
Start date
2022-01-31
Completion date
2023-02-11
Last updated
2022-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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?

Interventions

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

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.

Sponsors

University of New South Wales
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026