Corneal Endothelium After Phacoemulsification in Pseudo Exfoliation Syndrome

September 8, 2022 updated by: Hosny Ahmed Zein, Minia University

Corneal Endothelial Evaluation After Phacoemulsification in Eyes With Pseudoexfoliation Syndrome

To study corneal endothelial cells changes after phacoemulsification in patients with senile cataract and pseudoexfoliation syndrome (PEX) compared with control patients with senile cataract using specular microscope.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In a prospective interventional case-control study, 20 eyes with cataract and PEX and 20 control eyes with cataract without PXE were subjected to phacoemulsification and posterior chamber foldable intraocular lens implantation in Minia University Hospital and Genaidy Eye Center between March 2019 and December 2020. Specular microscopy was done preoperatively, 3 and 6 months postoperatively. Endothelium cell density (ECD), coefficient variation (CV), hexagonality, pleomorphism and corneal thickness were evaluated and compares between PXE and control eyes.

Study Type

Interventional

Enrollment (Actual)

40

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
    • Minia
      • Minya, Minia, Egypt, 61111
        • Minia University Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • senile cataract age more than 55 years

Exclusion Criteria:

  • PEX with glaucoma, eyes with cornea guttata or any corneal dystrophy, zonular dehiscence, very dense nuclear cataract (cataracta nigra) history of previous ocular surgery.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Corneal Endothelial Evaluation after Phacoemulsification in Eyes with Pseudoexfoliation Syndrome
Procedure: phacoemulsification
phacoemulsification with corneal endothelial evaluation by specular microscopy
Experimental: Corneal Endothelial Evaluation after Phacoemulsification in Eyes without Pseudoexfoliation
Procedure: phacoemulsification
phacoemulsification with corneal endothelial evaluation by specular microscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
corneal endothelial cell loss
Time Frame: 6 months
corneal endothelial cell loss
6 months

Collaborators and Investigators

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

Sponsor

Minia 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)

March 1, 2019

Primary Completion (Actual)

December 20, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

July 3, 2022

First Submitted That Met QC Criteria

July 3, 2022

First Posted (Actual)

July 7, 2022

Study Record Updates

Last Update Posted (Actual)

September 13, 2022

Last Update Submitted That Met QC Criteria

September 8, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEX2019

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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