The Correlation Between Pupil Size and Retinal Nerve Fibers Changes in Pseudoexfoliation Syndrome.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: optical coherence tomography.
- Who it may be relevant to
- Registry conditions: Pseudoexfoliation Syndrome. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device optical 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.
Primary outcome measures
- To study the possible correlation between pupillary diameter before and after dilation with intraocular pressure, lens stability and glaucomatous damage [Time frame: Baseline]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Tekin K, Kiziltoprak H, Sekeroglu MA, Yetkin E, Bayraktar S, Yilmazbas P. Static and dynamic pupil characteristics in pseudoexfoliation syndrome and glaucoma. Clin Exp Optom. 2020 May;103(3):332-338. doi: 10.1111/cxo.12945. Epub 2019 Jul 30. PMID 31364197
- Tuteja S, Zeppieri M, Chawla H. Pseudoexfoliation Syndrome and Glaucoma. StatPearls Publishing; 2023
- Katsi V, Pavlidis AN, Kallistratos MS, Fitsios A, Bratsas A, Tousoulis D, Stefanadis C, Manolis AJ, Kallikazaros I. Cardiovascular repercussions of the pseudoexfoliation syndrome. N Am J Med Sci. 2013 Aug;5(8):454-9. doi: 10.4103/1947-2714.117294. PMID 24083219
- Shazly TA, Farrag AN, Kamel A, Al-Hussaini AK. Prevalence of pseudoexfoliation syndrome and pseudoexfoliation glaucoma in Upper Egypt. BMC Ophthalmol. 2011 Jun 27;11:18. doi: 10.1186/1471-2415-11-18. PMID 21707986
- Plateroti P, Plateroti AM, Abdolrahimzadeh S, Scuderi G. Pseudoexfoliation Syndrome and Pseudoexfoliation Glaucoma: A Review of the Literature with Updates on Surgical Management. J Ophthalmol. 2015;2015:370371. doi: 10.1155/2015/370371. Epub 2015 Oct 29. PMID 26605078
- Sangal N, Chen TC. Cataract surgery in pseudoexfoliation syndrome. Semin Ophthalmol. 2014 Sep-Nov;29(5-6):403-8. doi: 10.3109/08820538.2014.959189. PMID 25325866
Identifiers
NCT: NCT06588816 · changes in pseudoexfoliation