Corneal Endothelium in Diabetics Undergoing Phacoemulsification

February 18, 2023 updated by: Rahma Rashad Helmy, Assiut University

Evaluation of Corneal Endothelium in Diabetic Patients Undergoing Phacoemulsification Using Specular Microscopy

evaluate and compare the changes in corneal endothelial cell count density between diabetic and non diabetic patients undergoing phacoemulsification surgery, and to evaluate the effect of duration, and control of diabetes on corneal morphology.

Study Overview

Status

Not yet recruiting

Conditions

Corneal Endothelial Cell Loss

Detailed Description

Diabetes mellitus (DM) is a major health hazard reaching epidemic proportions. Worldwide more than 285 million people are affected by DM; this number is expected to increase to 439 million by 2030 according to the international diabetes federation. DM affects every part of the body and the eye is not an exception.

Diabetes mellitus has been found to be detrimental to corneal endothelium . Patients with diabetes have been found to have morphologically abnormal endothelium, including pleomorphism and polymegethism. Also, elderly patients with diabetes mellitus undergo phacoemulsification is particularly vulnerable to greater endothelial damage during surgery than non diabetics.

Several studies showed that diabetes mellitus has a lower impact on corneal cell density and morphology in patients with good glycemic control , also patients with diabetes over 10 years have more corneal morphological abnormalities than those having diabetes under 10 years duration.

Patients with DM tend to develop cataract more frequently and earlier than non diabetics.

Corneal endothelium plays an important role in maintaining dehydrated state and transparency of cornea throughout life, by pumping excess fluid out of stroma through active transport mechanism and barrier function. Any compromise in these factors leads to direct effect on corneal endothelium .

Cataract has been documented to be the most significant cause of bilateral blindness .

Cataract extraction with phacoemulsification is one of the most common surgical procedure performed nowadays, with an estimated 19 million operation performed annually worldwide. The WHO states that this number will increase to 32 million by 2025, however corneal endothelium is known to undergo damage during phacoemulsification in many different ways, it may be injured mechanically as result of instrumentation causing postoperative complication such as corneal edema.

Specular microscopy is used for non invasive viewing and recording of the image of corneal endothelial cell layer. Several studies have used specular microscopy for quantitative assessment of the corneal damage associated with phacoemulsification by measuring the degree of decrease in the corneal cell density.

Study Type

Observational

Enrollment (Anticipated)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

evaluate the changes in corneal endothelium between 50 patients diabetic and non diabetic undergoing phacoemulsification

Description

Inclusion Criteria:

Age from 40 to 70
Any degree of cataract
No previous ocular surgery

Exclusion Criteria:

Any corneal pathology, infection, or active inflammation
pseudoexofoliation
History of ocular trauma or surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
corneal endothelium cell count Time Frame: baseline	normal range of 1500 to 3500 cells/mm2 (age, 40-90)	baseline
corneal endothelial cell size Time Frame: baseline	their dimension being roughly 50-70 μm long, 10-30 μm wide and 0.1-10 μm thick	baseline
corneal endothelial cell shape Time Frame: baseline	a single layer of cells organized in a characteristic honeycomb pattern	baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2023

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

August 13, 2022

First Submitted That Met QC Criteria

August 28, 2022

First Posted (Actual)

August 31, 2022

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 18, 2023

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

corneal endothelium

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.