Glycemic Control and Retinal Microvascular Changes

NCT06150495 | Unknown

• 1 other identifier: IRB no. 2021-06-029
• Study Type: observational
• Target: 259
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetic Retinopathy; Neurodegeneration; Blood Sugar; High

Outcome Measures

Primary Outcomes (3)

• The foveal avascular zone (FAZ) area (mm^2)

  FAZ was defined as the avascular area in the foveal center.

  Upon initial registration and through study completion, an average of 1 year

• central foveal retinal thickness (um) and macular ganglion cell-inner plexiform layer (GC-IPL) thickness (um)

  Retinal layer thickness were calculated automatically using the bundled software

  Upon initial registration and through study completion, an average of 1 year

• Retinal vessel density (VD, %)

  The VD (%) was calculated using the following formula: VD (%) = vascular area (pixel) / (total area - FAZ area) (pixel) × 100.

  Upon initial registration and through study completion, an average of 1 year

Study Arms (3)

Healthy control

The controls included patients without DM who presented for regular ophthalmic examination.

intensive control (IC) group

The mean HbA1c level was calculated during the 12 months prior to the OCT and OCTA. Based on the mean HbA1c level, T2DM patients were divided into intensive control (IC; mean HbA1c ≤ 7.0%) and moderate control (MC; mean HbA1c \> 7.0%) groups

moderate control (MC) group

The mean HbA1c level was calculated during the 12 months prior to the OCT and OCTA. Based on the mean HbA1c level, T2DM patients were divided into intensive control (IC; mean HbA1c ≤ 7.0%) and moderate control (MC; mean HbA1c \> 7.0%) groups

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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. The controls included patients without DM who presented for regular ophthalmic examination. One eye each of DM patients and controls was included in the study. The eye without significant ocular disease was selected from both eyes; if both eyes were eligible, the right eye was selected. The participants underwent comprehensive ophthalmic examination, including best-corrected visual acuity assessment using the Snellen chart, slit-lamp biomicroscopy, dilated fundus examination, ultra-widefield fundus photography, spectrum-domain OCT, and SS-OCTA. Patients with T2DM were included in the study after a retinal specialist confirmed absence of signs of DR on clinical examination and ultra-wide fundus photography.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Dongguk University Ilsan Hospital

Goyang-si, Republic of Korea, 10324, South Korea

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Nerve Degeneration; Hyperglycemia

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: November 29, 2023
• Study Start: January 1, 2019
• Primary Completion: August 31, 2022
• Study Completion: December 31, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

KR (1)