NCT07369388

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 18, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

January 18, 2026

Last Update Submit

January 18, 2026

Conditions

Endothelial Cell Density Loss

Keywords

Endothelial cellSpecular microscopyPhacoemulsification

Outcome Measures

Primary Outcomes (3)

  • Cell density

    1 week

  • Cell density

    1 month

  • Cell density

    3 months

Study Arms (2)

Diabetic group

ACTIVE COMPARATOR
Procedure: Phacoemulsification

Non-Diabetic group

ACTIVE COMPARATOR
Procedure: Phacoemulsification

Interventions

PhacoemulsificationPROCEDURE

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

Diabetic groupNon-Diabetic group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar university

Damietta, Egypt

Location

MeSH Terms

Interventions

Phacoemulsification

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Invistigator

Study Record Dates

First Submitted

January 18, 2026

First Posted

January 27, 2026

Study Start

May 1, 2025

Primary Completion

January 15, 2026

Study Completion

January 17, 2026

Last Updated

January 27, 2026

Record last verified: 2026-01

Locations

EG(1)