The Possible Association Between Pseudoexfoliation Syndrome And Corneal Endothelial Cell Changes

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.

Study Overview

• Status: Recruiting
• Conditions: Pseudoexfoliation Syndrome
• Intervention / Treatment: Other: no interventions as it is a case control observational study

Detailed Description

Pseudoexfoliation syndrome is a systemic, age related condition, characterized by the deposition of a basement membrane like material within the anterior segment of the eye, most notably on the anterior lens capsule, the iris, the anterior chamber angle, and the anterior vitreous. Both genetic and environmental factors may play a role in its pathogenesis . This condition may present unilaterally or bilaterally and is known to be a major risk factor for secondary open angle glaucoma. Pseudoexfoliation glaucoma is seen in up to 50% of eyes with pseudoexfoliation. In contrast to primary open angel glaucoma, this disease runs a more aggressive clinical course with high intraocular pressure at onset, fast rate of progression, poor the response to medical therapy is, as well as increased need for surgical intervention.

The prevalence of pseudoexfoliation syndrome demonstrates considerable geographic, ethnic and racial variation, ranging from low rates (< 6% in patients older than 70 years) to higher rates (more than 15%) in other regions. In Egypt, the reported incidence of pseudo-exfoliation syndrome in the population older than 40 years of age is 4.14%.

Several studies have shown the influence of pseudoexfoliation syndrome on the corneal endothelium cell density (ECD). Multiple studies showed decreased ECDs of patients with pseudoexfoliation syndrome compared to control patients. However, since the pseudoexfoliation syndrome varies greatly between different populations, in terms of prevalence and progression, it is valuable to study the potential corneal endothelial cell changes in an Egyptian population.

Factors that can change corneal density include Age, race, history of intraocular surgery, use of contact lenses and endothelial dystrophies. That's why in this study, history of intraocular surgery, corneal endothelial dystrophies and contact lens use are among exclusion criteria and includes patients 50 years in age or older.A low endothelial cell count may be a risk in cataract surgery if needed.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Ali Alhussaini, mbbch; Phone Number: 01124131377; Email: ali_alhossaini@yahoo.com

Study Locations

• Egypt
  • Asyut, Egypt, 71511
    • Recruiting
    • Assuit University
    • Contact: Ali Alhussaini, mbbch; Phone Number: 01124131377; Email: ali_alhossaini@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients above the age of 50 at the outpatient clinic

Description

Inclusion Criteria:

- 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
study group; patients with pseudoexfoliation fulfilling the inclusion criteria	Other: no interventions as it is a case control observational study; 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; no interventions as it is a case control observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
to determine the possible association between pseudoexfoliation syndrome and corneal endothelial cell changes by measuring:	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).; Pseudoexfoliation presence: to qualitatively categorize patients into one of two groups (pseudoexfoliation/ No pseudoexfoliation)	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
Endothelial cell morphology: to qualitatively categorize the patient subjectively into normal and abnormal shape using specular microscopy.	one year

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 24, 2022
• Primary Completion (Anticipated): July 24, 2022
• Study Completion (Anticipated): September 24, 2022

Study Registration Dates

• First Submitted: November 25, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Actual): December 14, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Pseudoexfoliation syndrome; Corneal endothelial count
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Uveal Diseases; Iris Diseases; Syndrome; Exfoliation Syndrome
• Other Study ID Numbers: AssiutUAA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No