NCT03741153

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2021

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

1.9 years

First QC Date

November 11, 2018

Last Update Submit

November 11, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • the percentage of diabetic patients with pseudo-exfoliation syndrome

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

    10 minutes

Study Arms (2)

study group

includes patients who will be diagnosed with Pseudoexfoliation syndrome

Device: slit lamp

control group

age matched controls who do not have Pseudoexfoliation syndrome

Device: slit lamp

Interventions

slit lampDEVICE

1. Presence of white grayish exfoliation material on the anterior lens capsule and / or the pupillary margin. 2. Poor pupillary dilatation due to atrophy of the dilator pupillae muscle. 3. The presence of pseudoexfoliative material (PXF)in cilliary processes and zonules. 4. presence of PXF material scattered on corneal endothelium. 5. Flecks of the exfoliative material on the anterior chamber which leads to glaucoma.

control groupstudy group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who will be diagnosed with pseudo-exfolian syndrome

You may qualify if:

  • Phakic patients presenting to Ophthalmology outpatient clinic Of Assiut University Hospital.

You may not qualify if:

  • Patients with previous intraocular surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lens Diseases

Interventions

Slit Lamp

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

OphthalmoscopesDiagnostic EquipmentEquipment and Supplies

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 11, 2018

First Posted

November 14, 2018

Study Start

January 1, 2019

Primary Completion

December 1, 2020

Study Completion

March 14, 2021

Last Updated

November 14, 2018

Record last verified: 2018-11