Back to resultsCorneal Endothelium After Phacoemulsification in Pseudo Exfoliation Syndrome
Primary Purpose
Corneal Endothelial Cell Loss, Pseudoexfoliation Syndrome
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
phacoemulsification
Sponsored by
About this trial
This is an interventional diagnostic trial for Corneal Endothelial Cell Loss focused on measuring corneal endothelial cell loss, pseudoexfoliation syndrome , cataract
Eligibility Criteria
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.
Sites / Locations
- Minia University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Corneal Endothelial Evaluation after Phacoemulsification in Eyes with Pseudoexfoliation Syndrome
Corneal Endothelial Evaluation after Phacoemulsification in Eyes without Pseudoexfoliation
Arm Description
Outcomes
Primary Outcome Measures
corneal endothelial cell loss
corneal endothelial cell loss
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05447130
Brief Title
Corneal Endothelium After Phacoemulsification in Pseudo Exfoliation Syndrome
Official Title
Corneal Endothelial Evaluation After Phacoemulsification in Eyes With Pseudoexfoliation Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 20, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Endothelial Cell Loss, Pseudoexfoliation Syndrome
Keywords
corneal endothelial cell loss, pseudoexfoliation syndrome , cataract
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Corneal Endothelial Evaluation after Phacoemulsification in Eyes with Pseudoexfoliation Syndrome
Arm Type
Experimental
Arm Title
Corneal Endothelial Evaluation after Phacoemulsification in Eyes without Pseudoexfoliation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
phacoemulsification
Intervention Description
phacoemulsification with corneal endothelial evaluation by specular microscopy
Primary Outcome Measure Information:
Title
corneal endothelial cell loss
Description
corneal endothelial cell loss
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Minia University Hospital
City
Minya
State/Province
Minia
ZIP/Postal Code
61111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Corneal Endothelium After Phacoemulsification in Pseudo Exfoliation Syndrome
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