Corneal Endothelium After Phacoemulsification in Pseudo Exfoliation Syndrome

• Sponsor: Minia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05447130
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 22
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Corneal Endothelial Cell Loss; Pseudoexfoliation Syndrome	Procedure: phacoemulsification	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Corneal Endothelial Evaluation After Phacoemulsification in Eyes With Pseudoexfoliation Syndrome
• Actual Study Start Date: Mar 1, 2019
• Actual Primary Completion Date: Dec 20, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. corneal endothelial cell loss [6 months]

   corneal endothelial cell loss

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Minia University Hospital	Minya	Minia	Egypt	61111

Sponsors and Collaborators

• Minia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hosny Ahmed Zein, DR, Minia University
• ClinicalTrials.gov Identifier: NCT05447130
• Other Study ID Numbers: PEX2019
• First Posted: Jul 7, 2022
• Last Update Posted: Jul 7, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hosny Ahmed Zein, DR, Minia University: corneal endothelial cell loss, pseudoexfoliation syndrome , cataract
• Additional relevant MeSH terms: Exfoliation Syndrome; Corneal Endothelial Cell Loss; Syndrome

Study Results

No Results Posted as of Jul 7, 2022