Skip to content

Autoregulation of retinal blood flow

Evaluating retinal blood flow autoregulation by means of Optical Coherence Tomography (OCT-A)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26189
Enrollment
125
Registered
2017-05-01
Start date
2017-09-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Hypotension Orthostatic hypotension Primary Vascular Dysregulation Migraine Hypertension Glaucoma

Interventions

None listed

Sponsors

University Medical Center Groningen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Any individual between 50 and 65 years old with healthy eyes (only mild refractive abnormalities corrected with glasses are allowed) and good overall health condition, having signed the consent form, and fitting the descriptions: - Group #1: Symptomatic low blood pressure individuals Defined as having at least one of: systolic blood pressure below 90 mmHg or diastolic blood pressure below 55 mmHg (without the use of any antihypertensive treatment), and at least one of (Appendix F1c): a) migraine: Migraine is defined as already diagnosed, or a score of 4 or 5 in the corresponding section of the questionnaire, according to the Migraine Screening Questionnaire (Positive Predictive Value: 95%, Negative Predictive Value: 94%).14 b) orthostatic hypotension: Orthostatic hypotension is defined as already diagnosed, or a sustained reduction of systolic blood pressure (SBP) of at least 20 mmHg or diastolic blood pressure (DBP) of 10 mmHg within 3 minutes of standing.15 c) cold intolerance: Cold intolerance is defined as a score of 30 or more in the corresponding section of the questionnaire.16 - Group #2: Asymptomatic low blood pressure individuals Defined as having at least one of: systolic blood pressure below 90 mmHg or diastolic blood pressure below 55 mmHg (without the use of any antihypertensive treatment), and none of the symptoms described in Group #1. - Group #3: Asymptomatic normal blood pressure individuals Defined as having systolic blood pressure between 110 and 140 mmHg, and diastolic blood pressure between 60 and 85 mmHg (without the use of any antihypertensive treatment), and none of the symptoms described in Group #1. - Group #4: Asymptomatic untreated high blood pressure individuals Defined as having at least one of: systolic blood pressure above 155 mmHg or diastolic blood pressure above 90 mmHg, not using any antihypertensive treatment, and having none of the symptoms described in Group #1. - Group #5: Treated high blood pressure individuals Defined as having systolic blood pressure below 125 mmHg and diastolic blood pressure below 75 mmHg, together with a medical history of hypertension and the use of any antihypertensive medication for at least the past 1 year.

Exclusion criteria

Exclusion criteria: •visual acuity less than 0.8 •IOP more than 21 mmHg •any visual field defect •sphere of more than (+/-)3D or cylinder of more than (+/-)2D •positive family history (father, mother, brother or sister) of glaucoma •OCT-A image quality of 6 or less, or any significant image artifact •pathological fundus photographs •diagnosed diabetes mellitus of any type •medical history of cerebrovascular disease, heart disease or severe anemia

Design outcomes

Primary

MeasureTime frame
Optic disc capillary density, macula capillary density, and arteriole diameter (assessed by OCT-A) as a function of blood pressure. The calculation of these parameters is based on custom MATLAB software that will be applied on the images.

Secondary

MeasureTime frame
Macula and RNFL thickness as a function of capillary density. The calculation of these parameters is based on software incorporated in the device that will be used (Canon OCT HS-100).

Contacts

Public ContactKonstantinos Pappelis

Dept. of Ophthalmology BB61 (secretary), PO Box 30.001

k.pappelis@umcg.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)