The Possible Association Between Pseudoexfoliation Syndrome And Corneal Endothelial Cell Changes

NCT05156138 | Unknown

• 1 other identifier: AssiutUAA
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to compare the endothelial cell count in patients with pseudoexfoliation syndrome to the the endothelial cell count in normal patients above the age of 50.

Conditions

Pseudoexfoliation Syndrome

Keywords

Pseudoexfoliation syndrome; Corneal endothelial count

Outcome Measures

Primary Outcomes (1)

• to determine the possible association between pseudoexfoliation syndrome and corneal endothelial cell changes by measuring:

  1. Endothelial cell density by specular microscopy to be categorized qualitatively into one of two groups (normal/abnormal cell count): A. A group with normal cell count (2100-3200 cells/mm2) B. A group with low or abnormal cell count (less than the previous range). 2. Pseudoexfoliation presence: to qualitatively categorize patients into one of two groups (pseudoexfoliation/ No pseudoexfoliation)

  one year

Secondary Outcomes (1)

• Endothelial cell morphology: to qualitatively categorize the patient subjectively into normal and abnormal shape using specular microscopy.

  one year

Study Arms (2)

study group

patients with pseudoexfoliation fulfilling the inclusion criteria

Other: no interventions as it is a case control observational study

control group

patients without pseudoexfoliation fulfilling the inclusion criteria

Other: no interventions as it is a case control observational study

Interventions

no interventions as it is a case control observational study OTHER

no interventions as it is a case control observational study

control group; study group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients above the age of 50 at the outpatient clinic

You may qualify if:

• \- Pesudoexfoliation Egyptian patients and controls groups must be at least 50 years old and matched from age.
• Controls will be selected from the same outpatient clinic.

You may not qualify if:

• Patients with history of previous intraocular surgeries, wearing contact lens and endothelial dystrophies.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit university

Asyut, 71511, Egypt

RECRUITING

MeSH Terms

Conditions

Exfoliation Syndrome

Condition Hierarchy (Ancestors)

Iris Diseases; Uveal Diseases; Eye Diseases

Central Study Contacts

Ali Alhussaini, mbbch

CONTACT

01124131377; ali_alhossaini@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 14, 2021
• Study Start: January 24, 2022
• Primary Completion: July 24, 2022
• Study Completion: September 24, 2022
• Last Updated: December 14, 2021

Record last verified: 2021-12

Locations

EG (1)