The Possible Association Between Pseudoexfoliation Syndrome And Corneal Endothelial Cell Changes

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05156138
Collaborator
(none)
50
1
8
6.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
The Possible Association Between Pseudoexfoliation Syndrome And Corneal Endothelial Cell Changes
Anticipated Study Start Date :
Jan 24, 2022
Anticipated Primary Completion Date :
Jul 24, 2022
Anticipated Study Completion Date :
Sep 24, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. to determine the possible association between pseudoexfoliation syndrome and corneal endothelial cell changes by measuring: [one year]

    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)

Secondary Outcome Measures

  1. Endothelial cell morphology: to qualitatively categorize the patient subjectively into normal and abnormal shape using specular microscopy. [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assuit university Asyut Egypt 71511

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ali Ashraf Alhussaini, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05156138
Other Study ID Numbers:
  • AssiutUAA
First Posted:
Dec 14, 2021
Last Update Posted:
Dec 14, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ali Ashraf Alhussaini, Principal Investigator, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 14, 2021