The Possible Association Between Pseudoexfoliation Syndrome And Corneal Endothelial Cell Changes

Pseudoexfoliation Syndrome Clinical Trial

Official title:

The Possible Association Between Pseudoexfoliation Syndrome And Corneal Endothelial Cell Changes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05156138
• Other study ID #: AssiutUAA
• Status: Recruiting
• Start date: January 24, 2022
• Est. completion date: September 24, 2022

Study information

• Verified date: December 2021
• Source: Assiut University
• Contact: Ali Alhussaini, mbbch
• Phone: 01124131377
• Email: ali_alhossaini[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 24, 2022
• Est. primary completion date: July 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Exfoliation Syndrome
• Pseudoexfoliation Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Egypt	Assuit university	Asyut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Endothelial cell morphology: to qualitatively categorize the patient subjectively into normal and abnormal shape using specular microscopy.		one year