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

NCT ID: NCT05778370

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-15
• Study Completion Date: 2023-12-01

Brief Summary

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.

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.

Conditions

Diabetic Retinopathy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

will include 15 patients (30 eyes) of age matched non-diabetic candidates (control group)

Swept Source Optical Coherence Tomography(Topcon DRI Triton)

Intervention Type: DEVICE

Topcon DRI Triton

Group 2

will include 15 patients (30 eyes) of diabetic patients with good glycemic control (HbA1c ≤7%),

Swept Source Optical Coherence Tomography(Topcon DRI Triton)

Intervention Type: DEVICE

Topcon DRI Triton

Group 3

will include 15 patients (30 eyes) of diabetic patients with poor glycemic control (HbA1c \<7% (

Swept Source Optical Coherence Tomography(Topcon DRI Triton)

Intervention Type: DEVICE

Topcon DRI Triton

Interventions

Swept Source Optical Coherence Tomography(Topcon DRI Triton)

Topcon DRI Triton

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Salma Gamal Nouby Mahmoud

Resident doctor at soad kafafi hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed S Saad, Prof

Role: STUDY_CHAIR

Assiut University

Mohamed Sharaf-Eldin, Dr

Role: STUDY_DIRECTOR

Assiut University

Dalia M Ali, Dr

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Salma G Nouby, Resident

Role: CONTACT

salmanouby@gmail.com

01124142121 ext. +20

Other Identifiers

HBA1c and OCT Macula

Identifier Type: -

Identifier Source: org_study_id