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NCT05447130 Clinical Trial

Corneal Endothelium After Phacoemulsification in Pseudo Exfoliation Syndrome

Pseudoexfoliation Syndrome Clinical Trial

Official title:
Corneal Endothelial Evaluation After Phacoemulsification in Eyes With Pseudoexfoliation Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05447130
Other study ID # PEX2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date December 31, 2020

Study information
Verified date September 2022
Source Minia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 31, 2020
Est. primary completion date December 20, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• phacoemulsification
phacoemulsification with corneal endothelial evaluation by specular microscopy

Locations
Country Name City State
Egypt Minia University Hospital Minya Minia

Sponsors (1)
Lead Sponsor Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary corneal endothelial cell loss corneal endothelial cell loss 6 months
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Completed NCT03453827 - Long-term Intraocular Lens (IOL) Decentration and Tilt in Eyes With Pseudoexfoliation Syndrome (PES) Following Cataract Surgery N/A