Specular Microscopy in Patients With Proliferative Diabetic Retinopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Argon Laser Panretinal Photocoagulation on Corneal Endothelial Cell Density .

NCT07157553

Panretinal Photocoagulation

NOT_YET_RECRUITING

Longitudinal Natural History Study of Retinal Function in Eyes of Patients With Diabetes

NCT07270133

Diabetic Retinal Disease

NOT_YET_RECRUITING

Skin and Retina Microvascular Endothelial Function in Healthy, Insulin Resistant and Type 2 Diabetic Subjects

NCT01241370

Diabetes Mellitus, Type 2

COMPLETED

A Multi-center Study to Evaluate Performance of an Automated Device for the Detection of Diabetic Retinopathy

NCT02963441

Diabetic Retinopathy

COMPLETED

Conbercept Injection in Treatment of Severe Proliferative Diabetic Retinopathy

NCT02816710

Proliferative Diabetic Retinopathy Tractional Retinal Detachment

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Chronic hyperglycemia can affect the corneal layers shape and functions. The resultant morphological and functional alterations increase the susceptibility of the cornea to recurrent corneal erosions, superficial keratitis, punctate epithelial keratopathy, impaired corneal sensitivity, and slowed healing capacity following trauma or surgical insult.

Considering the pivotal role of corneal endothelium in maintaining corneal clarity, several studies have investigated the possible alterations that take place in corneal endothelium in patients with DM . These studies found that DM can cause structural changes in corneal endothelial cells . Damaged corneal endothelium results in corneal oedema and increased central corneal thickness (CCT) . This increase has been documented in patients with DM as compared with healthy controls in a number of studies .

The aim of this study is to investigate the corneal endothelial cell profile and central corneal thickness in patients with proliferative diabetic retinopathy using non-contact specular microscopy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Corneal Endothelial Cell Changes in Diabetic Patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Specular microscopy

Non-contact Specular microscopy is a non-invasive method that allows for in vivo study of corneal endothelium.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No