Correlation Between Pupil Size and Ocular Signs of Pseudoexfoliation Syndrome

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT05113121
Collaborator
(none)
100
1
5.6
18

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: , Humphrey visual field (24-2) analysis and optical coherence tomography on retinal nerve fiber layer (RNFL) and ganglion cell complex.(GCC)

Detailed Description

For each patient. Full preoperative ophthalmological assessment will be done using slit lamp , size of the pupil in regular room light (usually around 2000 Lux) and post dilation with tropicamide 1%. baseline IOP measurement using Goldmann applanation tonometer, UCDVA (Uncorrected Distance Visual Acuity)and CDVA (Corrected Distance visual acuity), lens opacification or clarity, stability or subluxation. corneal endothelial cell count. Fundus examination using 90 D or 78D lenses, Humphrey visual field (24-2) analysis and optical coherence tomography on retinal nerve fiber layer (RNFL) and ganglion cell complex.(GCC)

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Correlation Between Pupil Size and Ocular Signs in Pseudoexfoliation Syndrome (PEX): a Contralateral Eye Study.
Actual Study Start Date :
Aug 25, 2021
Actual Primary Completion Date :
Jan 11, 2022
Actual Study Completion Date :
Feb 10, 2022

Outcome Measures

Primary Outcome Measures

  1. correlation between pupil size and severity of Pseudoexfoliation [2-3 months]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

All patients with pseudoexfoliation syndrome

Exclusion Criteria:

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut University Assiut Egypt

Sponsors and Collaborators

  • Assiut University

Investigators

  • Principal Investigator: Mahmoud Rateb, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mahmoud F. Rateb, Associate Professor, Assiut University
ClinicalTrials.gov Identifier:
NCT05113121
Other Study ID Numbers:
  • PEXPUPIL
First Posted:
Nov 9, 2021
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mahmoud F. Rateb, Associate Professor, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 12, 2022