Evaluation of Corneal Endothelium by Specular Microscope in Elderly Diabetic Patients

NCT ID: NCT06196333

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-05
• Study Completion Date: 2025-05-05

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 .

Conditions

Evaluation of Corneal Endothelium in Elderly Diabetic Patient

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Diabetes

Diabetes patients above 40 years

Non-contact specular microscopy

Intervention Type: DEVICE

using specular microscope to do morphological examination of corneal endothelial cells

Controls

Healthy controlled human beings have no medical histories

Non-contact specular microscopy

Intervention Type: DEVICE

using specular microscope to do morphological examination of corneal endothelial cells

Interventions

Non-contact specular microscopy

using specular microscope to do morphological examination of corneal endothelial cells

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Abanoub Hennis Mahrous

Resident doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

04-2023-200228

Identifier Type: -

Identifier Source: org_study_id