Quantitative analysis of retinal microcirculation in children with type 1 diabetes

Not Applicable

Completed

• Conditions: Retinal microcirculation and vessel density; Eye Diseases

• Registration Number: ISRCTN10866082
• Lead Sponsor: lucanlar Eye Training and Research Hospital

Brief Summary

2019 Results article in https://doi.org/10.1016/j.ajo.2019.04.011 (added 02/03/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-03-30
• Study Start: 2019-03-21
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Diabetic patient inclusion criteria:
1. Aged 6-18 years
2. Male and female
3. No previous known macular or other retinal changes,
4. No ocular problem other than spherical or cylindrical refractive errors = 1.00 diopter
5. No systemic disease except than Type 1 DM
6. The best-corrected vis6.ual acuity according to Snellen chart equal or greater than 20/20
7. A pre-prandial blood glucose level = 100 mg/dl under insulin treatment
8. Patients who had information about the duration of diabetes mellitus.

Control participant inclusion criteria:
1. Aged 6-18 years
2. Male and female
3. No systemic disease
4. No ocular problem other than spherical or cylindrical refractive errors = 1.00 diopter
5. Best-corrected visual acuity according to Snellen chart equal or greater than 20/20

Exclusion Criteria

All participants:
1. Strabismus
2. Nystagmus
3. History of previous ocular surgery or laser treatment
4. Trauma or uveitis
5. Corneal diseases such as corneal scar
6. Fundus abnormalities including diabetic retinopathy/maculopathy
7. Optic nerve diseases and glaucoma
8. Neurological disease or other diseases of the visual pathways
9. Ocular media opacities including cataract
10. Use of chronic topical medication
11. Those who are not sufficiently cooperative for optical coherence tomography angioraphy examinations

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Retinal microcirculation parameters and vessel density indexes are measured using an optical coherence tomography angiography device (the AngioVue device, Version 2017.1.0.151 of the RTVue XR Avanti, Opto-Vue, Inc, Fremont, CA, USA) at the single visit:<br> 1. Foveal zone vessel density: the area of the small circle, with a diameter of 1 mm<br> 2. Parafoveal zone vessel density: the area of the middle circle, with a diameter of 3 mm<br> 3. Perifoveal zone vessel density: the area of the outer circle with a diameter of 6 mm.<br> 4. Foveal avascular zone area<br> 5. Foveal avascular zone perimeter<br> 6. Acircularity index of foveal avascular zone: the ratio of the perimeter of the foveal avascular zone<br> 7. Foveal density (FD-300): vessel density in 300 microns around the foveal avascular zone<br>

Secondary Outcome Measures

Name	Time	Method
<br> All measurements taken at the single visit (on the day of ocular examination):<br> 1. Duration of diabetes mellitus (since the diagnosis of type 1 diabetes mellitus) measured using medical records<br> 2. Pre-prandial blood glucose and glycosylated hemoglobin (HbA1c) levels measured using blood samples in the diabetic group<br>