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The Possible Association Between Pseudoexfoliation Syndrome And Corneal Endothelial Cell Changes

NCT ID: NCT05156138

Last Updated: 2021-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-24

Study Completion Date

2022-09-24

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pseudoexfoliation Syndrome

Keywords

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Pseudoexfoliation syndrome Corneal endothelial count

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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study group

patients with pseudoexfoliation fulfilling the inclusion criteria

no interventions as it is a case control observational study

Intervention Type OTHER

no interventions as it is a case control observational study

control group

patients without pseudoexfoliation fulfilling the inclusion criteria

no interventions as it is a case control observational study

Intervention Type OTHER

no interventions as it is a case control observational study

Interventions

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no interventions as it is a case control observational study

no interventions as it is a case control observational study

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ali Ashraf Alhussaini

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assuit university

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ali Alhussaini, mbbch

Role: CONTACT

Phone: 01124131377

Email: [email protected]

Facility Contacts

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Ali Alhussaini, mbbch

Role: primary

Other Identifiers

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AssiutUAA

Identifier Type: -

Identifier Source: org_study_id