Glycemic Control and Retinal Microvascular Changes

Sponsor

Seoul National University Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06150495

Collaborator

(none)

259

Enrollment

Location

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy Neurodegeneration Blood Sugar; High

Study Design

Study Type:

Observational

Actual Enrollment :

259 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dongguk University Ilsan Hospital	Goyang-si	Republic Of Korea	Korea, Republic of	10324

Sponsors and Collaborators

Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT06150495

Other Study ID Numbers:

IRB no. 2021-06-029

First Posted:

Nov 29, 2023

Last Update Posted:

Nov 29, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 29, 2023