Association Between Pseudoexfoliation Syndrome and Diabetes Mellitus

The Possible Association Between Pseudoexfoliation Syndrome and Diabetes Mellitus in an Egyptian Population

Pseudoexfoliation syndrome (PEX) is characterized by the deposition of a distinctive fibrillar material in the anterior segment of the eye and was first described in 1917 by Lindberg. It is frequently associated with open angle glaucoma, known as pseudoexfoliation glaucoma, which is one of the most common identifiable forms of secondary open angle glaucoma worldwide. Despite extensive research, the exactchemical nature of the fibrillar material is unknown. It is believed to be secreted multifocally in the iris pigment epithelium, the ciliary epithelium, and the peripheral anterior lens epithelium.

Study Overview

• Status: Unknown
• Conditions: Lens Diseases
• Intervention / Treatment: Device: slit lamp

• Study Type: Observational
• Enrollment (Anticipated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients who will be diagnosed with pseudo-exfolian syndrome

Description

Inclusion Criteria:

• Phakic patients presenting to Ophthalmology outpatient clinic Of Assiut University Hospital.

Exclusion Criteria:

• Patients with previous intraocular surgery.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
study group; includes patients who will be diagnosed with Pseudoexfoliation syndrome	Device: slit lamp; Presence of white grayish exfoliation material on the anterior lens capsule and / or the pupillary margin.; Poor pupillary dilatation due to atrophy of the dilator pupillae muscle.; The presence of pseudoexfoliative material (PXF)in cilliary processes and zonules.; presence of PXF material scattered on corneal endothelium.; Flecks of the exfoliative material on the anterior chamber which leads to glaucoma.
control group; age matched controls who do not have Pseudoexfoliation syndrome	Device: slit lamp; Presence of white grayish exfoliation material on the anterior lens capsule and / or the pupillary margin.; Poor pupillary dilatation due to atrophy of the dilator pupillae muscle.; The presence of pseudoexfoliative material (PXF)in cilliary processes and zonules.; presence of PXF material scattered on corneal endothelium.; Flecks of the exfoliative material on the anterior chamber which leads to glaucoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the percentage of diabetic patients with pseudo-exfoliation syndrome	slit lamp examination of all diabetic patients to get the percentage of those with pseudo-exfoliation syndrome	10 minutes

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): March 14, 2021

Study Registration Dates

• First Submitted: November 11, 2018
• First Submitted That Met QC Criteria: November 11, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 11, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Eye Diseases; Endocrine System Diseases; Uveal Diseases; Iris Diseases; Diabetes Mellitus; Lens Diseases; Exfoliation Syndrome
• Other Study ID Numbers: PXSDM

Drug and device information, study documents

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