Skip to main content
Clinical Trials/NCT05838898
NCT05838898Not yet recruitingNot Applicable

Changes of Corneal Endothelial Cells in Patients With PDR Using Specular Microscopy

Assiut University0 sites60 target enrollmentStarted: June 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
60
Primary Endpoint
To predict the effect of Diabetes on the cornea of diabetic patients

Study Overview

Brief Summary

.1. corneal endothelial profile in patients with proliferative diabetic retinopathy compared to a healthy age-matched control group.

  1. The effect of the age, and duration of Diabetes on the corneal endothelium .

Detailed Description

Diabetes mellitus (DM) is a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both. The chronic hyperglycemia of diabetes is associated with long-term damage, dysfunction, and failure of different organs, especially the eyes, kidneys, nerves, heart, and blood vessels. In Egypt, diabetes is a growing public health problem.

Diabetes causes several ocular complications including diabetic retinopathy, cataract, glaucoma and ocular surface diseases.

Retinal damage caused by microangiopathy results in diabetic retinopathy which is one of the most important causes of blindness and affects approximately 40% of all diabetic patients.

Diabetic retinopathy is classified to non-proliferative diabetic retinopathy (NPDR) (mild, moderate, severe) and proliferative diabetic retinopathy (PDR) according to the severity of retinopathy.

Even though diabetic retinopathy is the most common sequel and most widely studied association of DM, other structures of the eye are not immune and get affected in various stages of the disease.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
40 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • patients with Type I or II Diabetes Mellitus
  • .Diagnosed with proliferative diabetic retinopathy . .Intraocular pressure less than 21mmHg.
  • Healthy controls:
  • .Healthy individuals aged 40 to 70 years of both sexes. .Intraocular pressure less than 21 mmHg.

Exclusion Criteria

  • Diabetic group:
  • Associated ocular diseases that may affect the corneal endothelium such as uveitis, glaucoma, and dystrophy, prolonged CLs use.
  • Previous ocular trauma or surgery.
  • Healthy control:
  • Any systemic diseases that may affect corneal endothelium function.
  • Associated ocular diseases that may affect the corneal endothelium such as uveitis, glaucoma, and dystrophy, prolonged CLs use.
  • Previous ocular trauma , surgery ,laser or intraocular injection.

Outcomes

Primary Outcomes

To predict the effect of Diabetes on the cornea of diabetic patients

Time Frame: Baseline

To evaluate corneal endothelial changes in patients with Proliferative diabetic retinopathy compared to normal group of the same age and gender using Specular microscopy

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marline Reda Fahim Anis

Ophthalmologist

Assiut University

Similar Trials

Specular Microscopy in Patients With... | Clinical Trial