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Clinical Trials/NCT06588816
NCT06588816
Not yet recruiting
Not Applicable

The Correlation Between Pupil Size and Retinal Nerve Fibers Changes in Pseudoexfoliation Syndrome.

Assiut University0 sites33 target enrollmentDecember 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pseudoexfoliation Syndrome
Sponsor
Assiut University
Enrollment
33
Primary Endpoint
To study the possible correlation between pupillary diameter before and after dilation with intraocular pressure, lens stability and glaucomatous damage
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

To study the possible correlation between pupillary diameter before and after dilation with intraocular pressure, lens stability and glaucomatous damage (represented by optic disc changes using cup to disc ratio and OCT changes in retinal nerve fiber layer and ganglion cell complex) in each eye of the same patient with PEX.

Detailed Description

Pseudoexfoliation (PEX) is a widespread condition that is often considered as a generalized disorder involving ocular manifestations as well as other body systems. It is characterized by the deposition of a distinctive fibrillar material in the anterior segment of the eye. The effect of pseudoexfoliation on various ocular tissues has been well studied in the past decades, especially both lens and optic disc damage. Key signs in pseudoexfoliative eyes are attributed to the effect of pseudoexfoliation material on pupillary muscles, lens and optic disc. Pseudoexfoliation appears to be a common disorder in older individuals in Upper Egypt with a prevalence of 4.14%. PXF was bilateral in 82.2% of cases. It was significantly associated with cataract, glaucoma and hearing loss. Of the PXF patients, 65% had cataract, 30.3% had glaucoma and 8.1% had hearing loss. Cardiovascular and cerebrovascular diseases such as angina, aortic aneurysm, and dementia have been linked to PXS. Subjects with PXF had a two- to three-fold increased risk for glaucoma according to the Blue Mountains Eye Study. The classic sign of PXF is the visualization of white pseudoexfoliative material on the pupil margin and on the anterior lens surface. It is believed that pupil size is another indicator for the severity of the disease. In this study we correlate the pupil size with other common ocular signs in PEX such as; lens subluxation and glaucomatous damage.

Registry
clinicaltrials.gov
Start Date
December 2024
End Date
March 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nayera Waleed Aboelwafa Mohamed

Resident

Assiut University

Eligibility Criteria

Inclusion Criteria

  • All patients with pseudoexfoliation syndrome.

Exclusion Criteria

  • previous ocular surgery or ocular trauma affecting the pupil. Any systemic or neurologic disease affecting the pupil

Outcomes

Primary Outcomes

To study the possible correlation between pupillary diameter before and after dilation with intraocular pressure, lens stability and glaucomatous damage

Time Frame: Baseline

in each eye of the same patient with PEX we study the correlation between the pupillary size before and after dilation with intraocular pressure, lens stability and glaucomatous damage represented by optic disc changes (cup to disc ratio) and OCT changes (RNFL and GCC).

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