Corneal Endothelium After Phacoemulsification in Pseudo Exfoliation Syndrome

NCT ID: NCT05447130

Last Updated: 2022-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Corneal Endothelial Cell Loss Pseudoexfoliation Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Corneal Endothelial Evaluation after Phacoemulsification in Eyes with Pseudoexfoliation Syndrome

Group Type EXPERIMENTAL

phacoemulsification

Intervention Type PROCEDURE

phacoemulsification with corneal endothelial evaluation by specular microscopy

Corneal Endothelial Evaluation after Phacoemulsification in Eyes without Pseudoexfoliation

Group Type EXPERIMENTAL

phacoemulsification

Intervention Type PROCEDURE

phacoemulsification with corneal endothelial evaluation by specular microscopy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

phacoemulsification

phacoemulsification with corneal endothelial evaluation by specular microscopy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Minia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hosny Ahmed Zein

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Minia University Hospital

Minya, Minya Governorate, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PEX2019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fuchs' Torsional Phaco Study
NCT00781027 COMPLETED PHASE4