Glycemic Control and Retinal Microvascular Changes

Glycemic Control and Retinal Microvascular Changes in Type 2 Diabetes Mellitus Patients Without Clinical Retinopathy

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06150495

Enrollment

259

Registered

2023-11-29

Start date

2019-01-01

Completion date

2025-12-31

Last updated

2023-11-29

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

Conditions

Blood Sugar; High, Diabetic Retinopathy, Neurodegeneration

Brief summary

The goal of this prospective, observational study is to compare in the association of glycemic control and retinal microvascular changes in patients with type 2 diabetes mellitus (T2DM) without diabetic retinopathy (DR). The main question it aims to answer are: • Do degenerative changes in retinal microvasculature or nerves depend on glycemic control even before diabetic retinopathy is detected? Participants will receive an annual routine comprehensive examination including ultra-widefield fundus photography, spectral domain optical coherence tomography (OCT), and swept-source optical coherence tomography angiography (OCTA).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* The study included 30-70-year-old patients with T2DM without known DR at baseline who underwent regular screening for DR at the department of ophthalmology. * Who underwent regular checkups for DR between January 2019 and August 2022 at Dongguk University Ilsan Hospital. * The controls included patients without DM who presented for regular ophthalmic examination.

Exclusion criteria

* patients with a history of retinal or choroidal diseases (i.e., age-related macular degeneration, retinal vein occlusion, uveitis, retinal detachment, and central serous chorioretinopathy), glaucoma, or optic neuropathy * patients with neurodegenerative diseases, such as Parkinson's disease and dementia.

Design outcomes

Primary

Measure	Time frame	Description
The foveal avascular zone (FAZ) area (mm^2)	Upon initial registration and through study completion, an average of 1 year	FAZ was defined as the avascular area in the foveal center.
central foveal retinal thickness (um) and macular ganglion cell-inner plexiform layer (GC-IPL) thickness (um)	Upon initial registration and through study completion, an average of 1 year	Retinal layer thickness were calculated automatically using the bundled software
Retinal vessel density (VD, %)	Upon initial registration and through study completion, an average of 1 year	The VD (%) was calculated using the following formula: VD (%) = vascular area (pixel) / (total area - FAZ area) (pixel) × 100.

Countries

South Korea

Outcome results