Characterising ocular blood flow changes with an exercise stimulus using optical coherence tomography angiography (OCT-A).

Not Applicable

Recruiting

• Conditions: ormal Tension Glaucoma; Diabetic Retinopathy; Normal Tension Glaucoma; Eye - Diseases / disorders of the eye; Cardiovascular - Normal development and function of the cardiovascular system; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12620000837921
• Lead Sponsor: niversity of NSW, Rural Clinical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-24
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Participation will be offered to patients aged between 18-75 years who attend the Port Macquarie Eye Centre (PMEC).

* Healthy controls: patients who attend the clinic for treatment of non-glaucomatous and non-diabetic issues.
* Normal tension glaucoma patients: normal tension glaucoma diagnosed by treating ophthalmologist with a peak IOP <21mmHg.
* Diabetic retinopathy patients: patients with diabetic retinopathy of ICDRSS grade mild or moderate without diabetic macular oedema.

Exclusion Criteria

* Inability to provide informed consent/assent
* Inability to sit at OCT/A
* Hand pathology: chronic hand pain due to any cause, broken skin on the palm or fingers, Rheumatoid Arthritis, hand surgery in the last 3 months
* Ocular pathology: cataracts of nuclear sclerotic grade >2+, refraction spherical equivalent < -3D or > +3D, prior corneal surgery or significant corneal disease, prior glaucoma drainage surgery, cataract surgery within the last 3 months
* Current known pregnancy
* Potentially vasoactive systemic or topical medications: blood pressure treatment particularly beta-blockers, calcium channel blockers, or alpha agonists

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To measure the change in peripapillary vessel density (arbitrary units; % difference) induced by isometric exercise using optical coherence tomography angiography (6x6mm scan) in healthy patients, and patients with normal tension glaucoma or diabetic retinopathy. [20 minutes prior to exercise, 10 minutes prior to exercise, 2 minutes into exercise (primary timepoint), and 10 minutes post-exercise.];To measure the change in macular vessel density (arbitrary units; % difference) induced by isometric exercise using optical coherence tomography angiography (6x6mm scan) in healthy patients, and patients with normal tension glaucoma or diabetic retinopathy. [20 minutes prior to exercise, 10 minutes prior to exercise, 2 minutes into exercise (primary timepoint), and 10 minutes post-exercise.]

Secondary Outcome Measures

Name	Time	Method
To establish the diagnostic accuracy of isometric-exercise OCT-A changes for determining healthy versus glaucomatous or diabetic eyes.<br>* OCTA changes will be determined by image intensity binarisation using a mean algorithm to give a validated measure of vessel density in arbitrary units<br>* Images at each timepoint will be co-registered to ensure comparable regions of interest are analysed<br>* Diagnostic accuracy will be measured using area under a Receiver Operator Characteristic curve, with cutoffs for sensitivity and specificity reported.[After image and data analysis.]