Association Between Pseudoexfoliation Syndrome and Diabetes Mellitus

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03741153
Collaborator
(none)
100
26.4

Study Details

Study Description

Brief Summary

Pseudoexfoliation syndrome (PEX) is characterized by the deposition of a distinctive fibrillar material in the anterior segment of the eye and was first described in 1917 by Lindberg. It is frequently associated with open angle glaucoma, known as pseudoexfoliation glaucoma, which is one of the most common identifiable forms of secondary open angle glaucoma worldwide. Despite extensive research, the exactchemical nature of the fibrillar material is unknown. It is believed to be secreted multifocally in the iris pigment epithelium, the ciliary epithelium, and the peripheral anterior lens epithelium.

Condition or Disease Intervention/Treatment Phase
  • Device: slit lamp

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Possible Association Between Pseudoexfoliation Syndrome and Diabetes Mellitus in an Egyptian Population
Anticipated Study Start Date :
Jan 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Mar 14, 2021

Arms and Interventions

Arm Intervention/Treatment
study group

includes patients who will be diagnosed with Pseudoexfoliation syndrome

Device: slit lamp
Presence of white grayish exfoliation material on the anterior lens capsule and / or the pupillary margin. Poor pupillary dilatation due to atrophy of the dilator pupillae muscle. The presence of pseudoexfoliative material (PXF)in cilliary processes and zonules. presence of PXF material scattered on corneal endothelium. Flecks of the exfoliative material on the anterior chamber which leads to glaucoma.

control group

age matched controls who do not have Pseudoexfoliation syndrome

Device: slit lamp
Presence of white grayish exfoliation material on the anterior lens capsule and / or the pupillary margin. Poor pupillary dilatation due to atrophy of the dilator pupillae muscle. The presence of pseudoexfoliative material (PXF)in cilliary processes and zonules. presence of PXF material scattered on corneal endothelium. Flecks of the exfoliative material on the anterior chamber which leads to glaucoma.

Outcome Measures

Primary Outcome Measures

  1. the percentage of diabetic patients with pseudo-exfoliation syndrome [10 minutes]

    slit lamp examination of all diabetic patients to get the percentage of those with pseudo-exfoliation syndrome

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Phakic patients presenting to Ophthalmology outpatient clinic Of Assiut University Hospital.
Exclusion Criteria:
  • Patients with previous intraocular surgery.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
gehad salah eldin galal, Principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT03741153
Other Study ID Numbers:
  • PXSDM
First Posted:
Nov 14, 2018
Last Update Posted:
Nov 14, 2018
Last Verified:
Nov 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 14, 2018