Endothelial Changes in Diabetic and Non-diabetic Patients Undergoing Phacoemulsification

January 18, 2026 updated by: Ehab Tharwat, Al-Azhar University

Specular Endothelial Changes in Diabetic and Non-diabetic Patients Undergoing Phacoemulsification

The aim of this study is to evaluate and compare specular endothelial changes in diabetic and non-diabetic patients undergoing phacoemulsification by assessing endothelial cell density, coefficient of variation, and percentage of hexagonal cells preoperatively and postoperatively. This study also seeks to provide updated evidence on the influence of diabetes on corneal endothelial response to cataract surgery and to support evidence-based strategies for optimizing surgical outcomes

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Damietta, Egypt
        • Al-Azhar University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 40 years
  • Presence of senile cataract suitable for phacoemulsification
  • Clear cornea with no clinical signs of endothelial decompensation
  • Ability to undergo specular microscopy examination
  • For the diabetic group: confirmed diagnosis of type 2 diabetes mellitus

Exclusion Criteria:

  • History of previous ocular surgery or trauma
  • Corneal pathology affecting the endothelium
  • Glaucoma or history of raised intraocular pressure
  • Pseudoexfoliation syndrome
  • Intraoperative complications

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diabetic group
Procedure: Phacoemulsification
Cataract surgery using phacoemulsification is the most frequently performed ophthalmic procedure worldwide and is considered a highly effective and safe method for visual rehabilitation
Active Comparator: Non-Diabetic group
Procedure: Phacoemulsification
Cataract surgery using phacoemulsification is the most frequently performed ophthalmic procedure worldwide and is considered a highly effective and safe method for visual rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cell density
Time Frame: 1 week
1 week
Cell density
Time Frame: 1 month
1 month
Cell density
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Al-Azhar 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 (Actual)

May 1, 2025

Primary Completion (Actual)

January 15, 2026

Study Completion (Actual)

January 17, 2026

Study Registration Dates

First Submitted

January 18, 2026

First Submitted That Met QC Criteria

January 18, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 18, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Endothelial Changes

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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