Skip to main content
Clinical Trials/NCT04965168
NCT04965168
Completed
Not Applicable

Evaluation of Corneal Endothelium Following Phacoemulsification in Diabetic and Non-diabetic Patients With Pseudoexfoliation Syndrome by Specular Microscopy

Minia University1 site in 1 country61 target enrollmentDecember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pseudoexfoliation
Sponsor
Minia University
Enrollment
61
Locations
1
Primary Endpoint
coefficient of variation (CV)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Our study is a comparative study, that was conducted to evaluate the corneal endothelial cells changes and central corneal thickness after uncomplicated phacoemulsification and intra ocular lens (IOL) implantation in normal controls, in non-diabetic and diabetic patients with PEX, and in patients with PEX only using specular microscopy.

Detailed Description

Our study is a comparative study that included 4 groups (controls, patients with PEX, non-diabetic patients with PEX, diabetic patients with PEX) to evaluate the corneal endothelial cells changes and central corneal thickness after uncomplicated phacoemulsification and intra ocular lens (IOL) implantation using specular microscopy, over a 6 months follow up period.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
October 16, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Minia University
Responsible Party
Principal Investigator
Principal Investigator

Heba Radi AttaAllah

Associate Professor of Ophthalmology

Minia University

Eligibility Criteria

Inclusion Criteria

  • Senile cataract with age between 50 to 70 years
  • Clear cornea with no zonuler dehiscence
  • Lens opacity classification system III (LOCS III), with grade 2-3 nuclear cataract with any additional cortical (C) and posterior sub capsular (P)

Exclusion Criteria

  • Uncontrolled DM in diabetic groups
  • Presence of autoimmune diseases
  • Patients with glaucoma
  • Corneal guttata
  • Zonular dehiscence
  • Rupture posterior capsule during cataract surgery

Outcomes

Primary Outcomes

coefficient of variation (CV)

Time Frame: 6 months

indicator of the uniformity of the size of endothelial cells

Percentage of hexagonal cells

Time Frame: 6 months

indicator of healthy endothelial cells

Central corneal thickness

Time Frame: 6 months

measurement of the distance between the epithelium and endothelium at the central cornea

endothelial cell density

Time Frame: 6 months

number of endothelial cells

Study Sites (1)

Loading locations...

Similar Trials