Analysis of eye vasculature anatomy and function using a novel non-invasive imaging device

Retinal Vascular Function Analysis using Optical Coherence Tomography Angiography

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN98388473

Enrollment

Registered

2018-10-04

Start date

2018-10-20

Completion date

Unknown

Last updated

2023-12-04

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

Conditions

Type 1 diabetes mellitus without diabetic retinopathy Nutritional, Metabolic, Endocrine Type 1 diabetes mellitus without diabetic retinopathy

Interventions

This study will involve type 1 diabetes (T1D) patients without diabetic retinopahty (DR), and a demographically similar control group. Both groups will be subjected to two standardized tests:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or older 2. Healthy 3. Type 1 diabetes

Exclusion criteria

Exclusion criteria: 1. Presence of significant lens opacities (Lens Opacities Classification System III stage 2 or more) 2. High refractive error (spherical equivalent below -6.50 or above +4.00 diopters) 3. History of glaucoma or ocular hypertension 4. Neuro-ophthalmic disease 5. Previous intraocular surgery 6. Untreated hypertension (systolic blood pressure >140 mmHg and diastolic blood pressure >90 mmHg) 7. Treated hypertension 8. Nephropathy 9. Other documented microvascular complication 10. Local or systemic inflammatory diseases 11. Taking vasoactive drugs 12. Smokers of more than 20 cigarettes per day 13. Pregnancy (urine pregnancy test performed if deemed necessary) Subjects will be asked to abstain from alcohol and caffeine for at least 6 hours before the study to reduce the possible autonomic effects and measurement bias.

Design outcomes

Primary

Measure	Time frame
To assess aims 1, 3, 4 and 5: 1. Macular vessel density, assessed using ocular coherence tomography angiography built-in software after the HCT test at the single study visit 2. Peripapillary vessel density, assessed using ocular coherence tomography angiography built-in software after the handgrip test at the single study visit To assess aim 2: 1. Macular vessel density, assessed using ocular coherence tomography angiography built-in software at the single study visit 2. Peripapillary vessel density, assessed using ocular coherence tomography angiography built-in software at the single study visit To assess aim 5: 1. Inflammatory cytokine (TNF and IL-1ß) concentration in tear and blood samples, assessed using ELISA at the single study visit	—

Measure

Time frame

To assess aims 1, 3, 4 and 5: 1. Macular vessel density, assessed using ocular coherence tomography angiography built-in software after the HCT test at the single study visit 2. Peripapillary vessel density, assessed using ocular coherence tomography angiography built-in software after the handgrip test at the single study visit To assess aim 2: 1. Macular vessel density, assessed using ocular coherence tomography angiography built-in software at the single study visit 2. Peripapillary vessel density, assessed using ocular coherence tomography angiography built-in software at the single study visit To assess aim 5: 1. Inflammatory cytokine (TNF and IL-1ß) concentration in tear and blood samples, assessed using ELISA at the single study visit

—

Secondary

Measure	Time frame
To assess all aims: 1. Metabolic data regarding diabetic disease: 1.1. HbA1c values, assessed using a standard laboratory test with a blood sample at the single study visit 1.2. Length of disease, assessed using a chart review of the patient at the single study visit To assess aims 1, 3, 4 and 5: 1. Changes in cardiorespiratory parameters in relation to macular and peripapillary vessel density change: 1.1. Heart rate, assessed using a polygraph and an oximeter from a single finger throughout the single study visit 1.2. Electrocardiography RR-interval variability, assessed using polygraph and an oximeter from a single finger during the HCT test at the single study visit 1.3. Arterial pressure, assessed using a polygraph and an oximeter from a single finger throughout the single study visit 1.4. Oxygen desaturation index, assessed using polygraph and an oximeter from a single finger during the HCT test at the single study visit 1.5. Respiratory rate, assessed using a polygraph with a respiratory band during the HCT test at the single study visit To assess aims 2 and 5: 1. Inflammatory cytokine (TNF and IL-1ß) concentration in tear and blood samples, assessed using ELISA at the baseline	—

Measure

Time frame

To assess all aims: 1. Metabolic data regarding diabetic disease: 1.1. HbA1c values, assessed using a standard laboratory test with a blood sample at the single study visit 1.2. Length of disease, assessed using a chart review of the patient at the single study visit To assess aims 1, 3, 4 and 5: 1. Changes in cardiorespiratory parameters in relation to macular and peripapillary vessel density change: 1.1. Heart rate, assessed using a polygraph and an oximeter from a single finger throughout the single study visit 1.2. Electrocardiography RR-interval variability, assessed using polygraph and an oximeter from a single finger during the HCT test at the single study visit 1.3. Arterial pressure, assessed using a polygraph and an oximeter from a single finger throughout the single study visit 1.4. Oxygen desaturation index, assessed using polygraph and an oximeter from a single finger during the HCT test at the single study visit 1.5. Respiratory rate, assessed using a polygraph with a respiratory band during the HCT test at the single study visit To assess aims 2 and 5: 1. Inflammatory cytokine (TNF and IL-1ß) concentration in tear and blood samples, assessed using ELISA at the baseline

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Countries

Portugal

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026