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Completed

NCT Number: NCT07369388

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

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Key information

Conditions

Endothelial Cell Density Loss

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar university

Damietta, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

phacoemulsification

Procedure

Cataract surgery using phacoemulsification is the most frequently performed ophthalmic procedure worldwide and is considered a highly effective and safe method for visual rehabilitation

Primary outcomes

  1. Cell density

    Time frame: 1 week

  2. Cell density

    Time frame: 1 month

  3. Cell density

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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