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Quantitative analysis of retinal microcirculation in children with type 1 diabetes

Changes in retinal microcirculation precede the clinical onset of diabetic retinopathy in children with type 1 diabetes mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN10866082
Enrollment
110
Registered
2019-03-21
Start date
2017-06-15
Completion date
Unknown
Last updated
2022-03-14

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

Conditions

Retinal microcirculation and vessel density Eye Diseases

Interventions

All participants attend a single study visit, at which they undergo a comprehensive ophthalmic examination including best corrected visual acuity tests using the Snellen chart, intraocular pressure me

Sponsors

Ulucanlar Eye Training and Research Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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: 1. Foveal zone vessel density: the area of the small circle, with a diameter of 1 mm 2. Parafoveal zone vessel density: the area of the middle circle, with a diameter of 3 mm 3. Perifoveal zone vessel density: the area of the outer circle with a diameter of 6 mm. 4. Foveal avascular zone area 5. Foveal avascular zone perimeter 6. Acircularity index of foveal avascular zone: the ratio of the perimeter of the foveal avascular zone 7. Foveal density (FD-300): vessel density in 300 microns around the foveal avascular zone

Secondary

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

Countries

Turkey

Outcome results

None listed

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