Evaluation of Corneal Endothelium by Specular Microscope in Elderly Diabetic Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Evaluation of Corneal Endothelium in Elderly Diabetic Patient
• Intervention / Treatment: Device: Non-contact specular microscopy

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 Type: Observational
• Enrollment (Estimated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Not gender based from 40 years to 80 years diabetic patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diabetes; Diabetes patients above 40 years	Device: Non-contact specular microscopy; using specular microscope to do morphological examination of corneal endothelial cells
Controls; Healthy controlled human beings have no medical histories	Device: Non-contact specular microscopy; using specular microscope to do morphological examination of corneal endothelial cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial count	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	15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlated change	Correlated change of corneal endotheliam to duration and control of DM	15 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): February 5, 2024
• Primary Completion (Estimated): November 5, 2024
• Study Completion (Estimated): May 5, 2025

Study Registration Dates

• First Submitted: December 25, 2023
• First Submitted That Met QC Criteria: December 25, 2023
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: December 25, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 04-2023-200228

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes