Correlation Between HBA1c Level and Thickness of Both Macula and Choroid in Patients With Type 2 Diabetes Mellitus

March 19, 2023 updated by: Salma Gamal Nouby Mahmoud, Assiut University
Diabetic retinopathy (DR) is a frequent cause of visual impairment, and the leading cause of blindness in those of working age, but it develops silently along years, producing symptoms only in late stages.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The risk of sight-threatening consequences can be reduced if the lesions are detected before irreversible damage to retinal function has developed .Patients with diabetes mellitus (DM) have many pathological changes in their macula as diabetic macular edema (DME), exudates, cysts, detachment and ischemia that cause impairment of vision.

DME is characterized by increased vascular permeability and deposition of hard exudates at the macula and can occur at any stage of DR. With the help of OCT, it is possible to quantify the macular thickness objectively and to follow the progression of DME quantitatively.

Currently, DME is classified as 'center involved' or 'non center involved' (referring to whether or not there is oedema i.e., CMT>250 μm at the fovea) based on OCT. Non-centre involved macular oedema is rarely symptomatic. However, as the oedema spreads to the central macula, patients usually experience progressive vision loss and treatment with anti-VEGF is recommended.

Also, DM can cause many pathological changes in the choroid as increased tortuosity, focal vascular dilatation, microaneurysms and nonperfused areas. Studies have analyzed choroidal thickness changes in DR using spectral domain optic coherence tomography. A number of studies have shown that choroidal thickness decreases as the diabetic retinopathy progresses.

Swept-source (SS) OCT is a variation of OCT that offers improvements in visualizing the vitreous, retina, and choroid at one image. The increased scan speeds, decreased signal attenuation, more comprehensive imaging, and deeper tissue penetration make SS-OCT ideal for capturing a wide range of views and studying structures below the retinal pigmented epithelium (RPE), especially the choroid.

Glycated haemoglobin (HbA1c) is measured primarily to identify the average plasma glucose concentration over prolonged periods and reflect the long-term control of hyperglycaemia. Higher levels of HbA1c increase the incidence of DME over a 10-year period in Wisconsin Epidemiology Study of Diabetic Retinopathy (WESDR). The Diabetes Control and Complication Trial (DCCT) and the UK Prospective Diabetic Study (UKPDS) both of which were randomized prospective studies showed that intensive glycaemic control and thus reduction of HbA1c levels are associated with a decrease in the rates of development and progression of DR and DME.

The use of HbA1c for the diagnosis of DM has been approved by the WHO based on a number of epidemiological studies showing that a threshold for increased prevalence of microvascular complications can be observed at HbA1c level of 6.5% .

Aim of the work To investigate the correlation between HbA1c levels in patients with type II diabetes mellitus on central macular thickness as well as central choroidal thickness using swept source optical coherence tomography.

Study Type

Observational

Enrollment (Anticipated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  1. Patients with type II diabetes mellitus and their age above 30 years.
  2. healthy population above 30 (for control group)

Description

Inclusion Criteria:

  • • Patients with type II diabetes mellitus and their age above 30 years.

    • No history of any previous ocular surgery.

Exclusion Criteria:

  1. Unregulated arterial blood pressure, or cardiovascular disorder.
  2. Media opacity that affects posterior pole imaging by OCT
  3. Hyperopia of 4 diopters (D)
  4. Myopia of -6 D.
  5. Age related macular degeneration and other retinal or choroidal pathologies.
  6. Any history of previous eye surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
will include 15 patients (30 eyes) of age matched non-diabetic candidates (control group)
Device: Swept Source Optical Coherence Tomography(Topcon DRI Triton)
Topcon DRI Triton
Group 2
will include 15 patients (30 eyes) of diabetic patients with good glycemic control (HbA1c ≤7%),
Device: Swept Source Optical Coherence Tomography(Topcon DRI Triton)
Topcon DRI Triton
Group 3
will include 15 patients (30 eyes) of diabetic patients with poor glycemic control (HbA1c <7% (
Device: Swept Source Optical Coherence Tomography(Topcon DRI Triton)
Topcon DRI Triton

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between HBA1c level and thickness of both macula and choroid in patients with type II diabetes mellitus
Time Frame: baseline
Taking oct record for diabetic patients already know their HBA1c level ( done within 3 months max ) . Without follow up Findings will be compared controlled and non controlled group and with control group (normal people) To correlate if there's relavence between the Hba1c and macular thickness
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Mohamed S Saad, Prof, Assiut University
  • Study Director: Mohamed Sharaf-Eldin, Dr, Assiut University
  • Principal Investigator: Dalia M Ali, Dr, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 15, 2023

Primary Completion (Anticipated)

November 15, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

March 4, 2023

First Submitted That Met QC Criteria

March 19, 2023

First Posted (Actual)

March 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 19, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBA1c and OCT Macula

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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