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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06588816
Enrollment
33
Registered
2024-09-19
Start date
2024-12-31
Completion date
2027-03-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pseudoexfoliation Syndrome

Keywords

pupil, pseudoexfoliation, pupil dilation, pupil size, pseudoexfoliation syndrome

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.

Interventions

DEVICEoptical coherence tomography

Optical coherence tomography (OCT) is a non-invasive imaging test . It uses light waves to take cross-section pictures of the retina . With OCT, the ophthalmologist can see each of the retina's distinctive layers, and so we can use it to study the changes in pseudoexfoliation syndrome.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To study the possible correlation between pupillary diameter before and after dilation with intraocular pressure, lens stability and glaucomatous damageBaselinein 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).

Contacts

Primary ContactNayera Waleed Aboelwafa Mohamed, Resident
Nayera.16285217@med.aun.edu.eg+201123118005
Backup ContactMohamed Omar Mohamed, Doctor
mohamedomar@aun.edu.eg+201119156644

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026