NCT03265457

Brief Summary

Pseudoexfoliation Syndrome Is a common disorder in Egypt. IT is one of the common causes of coexisting cataract and glaucoma. It may be associated with a less than normal endothelial count.

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
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

1 year

First QC Date

August 26, 2017

Last Update Submit

June 25, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparison between endothelial cell count in patients with Pseudoexfoliation syndrome and age matched controls.

    The corneal Endothelial cell count in patients with pseudoexfoliation syndrome will be measured by the specular microscopy \& compared with the normal endothelial count in people at the same group

    One year

Study Arms (2)

patient with pseudoexfoliation syndrome

The corneal Endothelial cell count will be measured by specular microscopy

Other: Specular microscopy

Normal people at same age

Other: Specular microscopy

Interventions

Comparison between corneal Endothelial count in patients with pseudoexfoliation syndrome and age matched group

Normal people at same agepatient with pseudoexfoliation syndrome

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with pseudoexfoliation syndrome

You may qualify if:

  • Patients with pseudoexfoliation syndrome

You may not qualify if:

  • Patients with previous intra ocular surgeries.
  • Patients with uveitis
  • Patients with fuck's endothelial dystrophy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Miyake K, Matsuda M, Inaba M. Corneal endothelial changes in pseudoexfoliation syndrome. Am J Ophthalmol. 1989 Jul 15;108(1):49-52. doi: 10.1016/s0002-9394(14)73259-3.

    PMID: 2750833BACKGROUND

MeSH Terms

Conditions

Exfoliation Syndrome

Condition Hierarchy (Ancestors)

Iris DiseasesUveal DiseasesEye Diseases

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

August 26, 2017

First Posted

August 29, 2017

Study Start

October 1, 2018

Primary Completion

October 1, 2019

Study Completion

October 1, 2020

Last Updated

June 26, 2018

Record last verified: 2018-06