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Clinical Trials/NCT07369388
NCT07369388CompletedNot Applicable

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

Al-Azhar University1 site in 1 country100 target enrollmentStarted: May 1, 2025Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Cell density

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

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

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

Arms & Interventions

Diabetic group

Active Comparator

Intervention: Phacoemulsification (Procedure)

Non-Diabetic group

Active Comparator

Intervention: Phacoemulsification (Procedure)

Outcomes

Primary Outcomes

Cell density

Time Frame: 1 week

Cell density

Time Frame: 1 month

Cell density

Time Frame: 3 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ehab Tharwat

Principal Invistigator

Al-Azhar University

Study Sites (1)

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