Correlation Between Pupil Size and Ocular Signs of Pseudoexfoliation Syndrome

NCT05113121 | Completed

• 1 other identifier: PEXPUPIL
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To study possible correlation between the size of the pupil in both room light and after dilation between both eyes in bilateral pseudoexfoliation with Intraocular pressure, lens clarity and stability, Optic disc , Visual changes and glaucoma changes by optical coherence tomography

Conditions

Pseudoexfoliation Syndrome; Pseudoexfoliation Glaucoma in Both Eyes; Pseudoexfoliation of Lens; Glaucoma

Keywords

cataract; glaucoma

Outcome Measures

Primary Outcomes (1)

• correlation between pupil size and severity of Pseudoexfoliation

  in each eye of the same patient we study correlation between pupil size with ntraocular pressure, lens status, corneal endothelial count and glaucomatous damage represented by (optic disc changes (cup to disc ratio) and OCT changes (RNFL and GCC)

  2-3 months

Interventions

, Humphrey visual field (24-2) analysis and optical coherence tomography on retinal nerve fiber layer (RNFL) and ganglion cell complex.(GCC) DIAGNOSTIC_TEST

, Humphrey visual field (24-2) analysis and optical coherence tomography on retinal nerve fiber layer (RNFL) and ganglion cell complex.(GCC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients , age : 18 years and older

You may qualify if:

• All patients with pseudoexfoliation syndrome

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (4)

• 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

• 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

• Akman A, Yilmaz G, Oto S, Akova YA. Comparison of various pupil dilatation methods for phacoemulsification in eyes with a small pupil secondary to pseudoexfoliation. Ophthalmology. 2004 Sep;111(9):1693-8. doi: 10.1016/j.ophtha.2004.02.008.

  PMID: 15350324 BACKGROUND

MeSH Terms

Conditions

Exfoliation Syndrome; Glaucoma; Cataract

Condition Hierarchy (Ancestors)

Iris Diseases; Uveal Diseases; Eye Diseases; Ocular Hypertension; Lens Diseases

Study Officials

• Mahmoud Rateb

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 9, 2021
• Study Start: August 25, 2021
• Primary Completion: January 11, 2022
• Study Completion: February 10, 2022
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after completion of data and for five years.
• Access Criteria: It will be upon request through email

Locations

EG (1)