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

NCT06588816 | Not Yet Recruiting

• 1 other identifier: changes in pseudoexfoliation
• Study Type: observational
• Target: 33
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pseudoexfoliation Syndrome

Keywords

pupil; pseudoexfoliation; pupil dilation; pupil size; pseudoexfoliation syndrome

Outcome Measures

Primary Outcomes (1)

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

  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).

  Baseline

Interventions

optical coherence tomography DEVICE

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with pseudoexfoliation syndrome

You may qualify if:

• All patients with pseudoexfoliation syndrome.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• 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 BACKGROUND

• Tuteja S, Zeppieri M, Chawla H. Pseudoexfoliation Syndrome and Glaucoma. 2023 May 31. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK574522/

  PMID: 34662036 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Exfoliation Syndrome; Mydriasis

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Iris Diseases; Uveal Diseases; Eye Diseases; Pupil Disorders

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Central Study Contacts

Nayera Waleed Aboelwafa Mohamed, Resident

CONTACT

+201123118005; Nayera.16285217@med.aun.edu.eg

Mohamed Omar Mohamed, Doctor

CONTACT

+201119156644; mohamedomar@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09