Evaluation of Corneal Endothelium by Specular Microscope in Elderly Diabetic Patients

Not yet recruiting

• Conditions: Evaluation of Corneal Endothelium in Elderly Diabetic Patient
• Interventions: Device: Non-contact specular microscopy

• Registration Number: NCT06196333
• Lead Sponsor: Assiut University

Brief Summary

A low endothelial count with endothelial pump dysfunction can contribute to corneal stromal hydration and loss of vision that can only be reversed by corneal transplantation,so this research proposed to detect any corneal endothelial changes related to DM , its duration and control of diabetes.

Detailed Description

- To establish any correlation between endothelial changes , and the duration of diabetes, hemoglobin A1c (HbA1c) by using specular microscope to do morphological examination of corneal endothelial cells, makes the measurement of mean cell density (MCD), measurement of coefficient of variation (CV) in the cell size as well as hexagonal appearance of the cell. These parameters provide the functional status index of the corneal endothelial layer .

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-25
• Study First Submitted QC: 2023-12-25
• Last Update Submitted: 2023-12-25
• Study First Posted: 2024-01-09
• Last Update Posted: 2024-01-09
• Study Start: 2024-02-05
• Primary Completion: 2024-11-05
• Study Completion: 2025-05-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• • Diabetic patient type 2
• Elderly patients above 40 years old

Exclusion Criteria

• • Patients with any of the following conditions have been omitted from the study included a past medical history of ocular trauma, corneal or intraocular inflammation, the use of systemic drugs that could affect endothelial cells, evidence of endothelial disease during a slit-lamp examination, previous ocular surgery (including cataract surgery), increased intraocular pressure, corneal opacity, or retinal photocoagulation procedures.
• non of the inclusion criteria patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetes	Non-contact specular microscopy	Diabetes patients above 40 years
Controls	Non-contact specular microscopy	Healthy controlled human beings have no medical histories

Primary Outcome Measures

Name	Time	Method
Endothelial count	15 months	Corneal endothelial cell count, coefficient of variation, percentage of hexagonal cells and central corneal thickness will be evaluated and correlated to known normal values in the same healthy individual age group

Secondary Outcome Measures

Name	Time	Method
Correlated change	15 months	Correlated change of corneal endotheliam to duration and control of DM