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临床试验/NCT06588816
NCT06588816尚未招募不适用

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

Assiut University0 个研究点目标入组 33 人开始时间: 2024年12月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
33
主要终点
To study the possible correlation between pupillary diameter before and after dilation with intraocular pressure, lens stability and glaucomatous damage

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients with pseudoexfoliation syndrome.

排除标准

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

结局指标

主要结局

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

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nayera Waleed Aboelwafa Mohamed

Resident

Assiut University

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