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

Not Applicable

Completed

• Conditions: Type 1 diabetes mellitus without diabetic retinopathy; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN98388473
• Lead Sponsor: Centro de Estudos Ciências da Visão - FM

Brief Summary

2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29160042 results 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32574352/ (added 21/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-04
• Study Completion: 2019-11-30
• Last Update Posted: 4 December 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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