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

NCT05778370 | Unknown FDA Device

• 1 other identifier: HBA1c and OCT Macula
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• Correlation between HBA1c level and thickness of both macula and choroid in patients with type II diabetes mellitus

  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

Study Arms (3)

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)

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)

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)

Interventions

Swept Source Optical Coherence Tomography(Topcon DRI Triton) DEVICE

Topcon DRI Triton

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• Patients with type II diabetes mellitus and their age above 30 years.
• No history of any previous ocular surgery.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Mohamed S Saad, Prof

  Assiut University

  STUDY CHAIR

• Mohamed Sharaf-Eldin, Dr

  Assiut University

  STUDY DIRECTOR

• Dalia M Ali, Dr

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salma G Nouby, Resident

CONTACT

01124142121; salmanouby@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor at soad kafafi hospital

Study Record Dates

• First Submitted: March 4, 2023
• First Posted: March 21, 2023
• Study Start: April 15, 2023
• Primary Completion: November 15, 2023
• Study Completion: December 1, 2023
• Last Updated: March 21, 2023

Record last verified: 2023-03