NCT05194891

Brief Summary

this study aimed to evaluate the corneal endothelial cell changes before and after phacoemulsification in pseudoexfoliative patients relative to healthy adults.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

January 31, 2022

Status Verified

January 1, 2022

Enrollment Period

1 year

First QC Date

January 4, 2022

Last Update Submit

January 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Study of corneal endothelial changes in pseudoexfoliation syndrome

    Comparison of corneal endothelial changes after phacoemulsification in patients with pseudoexfoliation and patient with cataract only

    Baseline

Interventions

Specular MicroscopyDIAGNOSTIC_TEST

Phacoemulsification

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This prospective, non-randomized comparative ,interventional study was performed on 100 eyes of 100 patients who were divided equally into two groups (pseudoexfoliative and control). Patient who aged above50 years and with nuclear cataract grade II,III, clear cornea and endothelial cell density more than 1000\\mm2 were included in this study. Also, patients with normal anterior chamber depth, dilatable pupil and with no active ocular disease or inflammation were included. Pseudoexfoliative patients who had glaucoma were excluded from the study.

You may qualify if:

  • Patient age is above50 years.
  • Patient with nuclear cataract grade II, III.
  • Clear cornea with no evidence of endothelial disease.
  • Endothelial cell density more than 1000\\mm2.
  • Normal anterior chamber depth and dilatable pupil.
  • No active ocular disease or inflammation.
  • Pseudoexfoliative patients.

You may not qualify if:

  • History of previous trauma, intraocular surgery or ocular surface infection in recent two weeks.
  • Presence of any corneal opacity, endothelial disease, scarring or dystrophies.
  • Pseudoexfoliative glaucoma.
  • Patients age below 50 years.
  • Endothelial cell count less than 1000\\mm2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Corneal Endothelial Cell Loss

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesEye ManifestationsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Shymaa Sabet, Doctor

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shymaa Ahmed, Doctor

CONTACT

Hassan Shams Eldeen, Assis. Prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 4, 2022

First Posted

January 18, 2022

Study Start

February 1, 2022

Primary Completion

February 1, 2023

Study Completion

March 1, 2023

Last Updated

January 31, 2022

Record last verified: 2022-01