NCT05447130

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2020

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

1.8 years

First QC Date

July 3, 2022

Last Update Submit

September 8, 2022

Conditions

Corneal Endothelial Cell LossPseudoexfoliation Syndrome

Keywords

corneal endothelial cell loss, pseudoexfoliation syndrome , cataract

Outcome Measures

Primary Outcomes (1)

  • corneal endothelial cell loss

    corneal endothelial cell loss

    6 months

Study Arms (2)

Corneal Endothelial Evaluation after Phacoemulsification in Eyes with Pseudoexfoliation Syndrome

EXPERIMENTAL
Procedure: phacoemulsification

Corneal Endothelial Evaluation after Phacoemulsification in Eyes without Pseudoexfoliation

EXPERIMENTAL
Procedure: phacoemulsification

Interventions

phacoemulsificationPROCEDURE

phacoemulsification with corneal endothelial evaluation by specular microscopy

Corneal Endothelial Evaluation after Phacoemulsification in Eyes with Pseudoexfoliation SyndromeCorneal Endothelial Evaluation after Phacoemulsification in Eyes without Pseudoexfoliation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • senile cataract age more than 55 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University Hospital

Minya, Minya Governorate, 61111, Egypt

Location

MeSH Terms

Conditions

Corneal Endothelial Cell LossExfoliation SyndromeCataract

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesEye ManifestationsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsIris DiseasesUveal DiseasesLens Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 3, 2022

First Posted

July 7, 2022

Study Start

March 1, 2019

Primary Completion

December 20, 2020

Study Completion

December 31, 2020

Last Updated

September 13, 2022

Record last verified: 2022-09

Locations

EG(1)