NCT03078387

Brief Summary

This study shows how careful ophthalmic examination of two patients showed signs of simultaneous bilateral retinal emboli. Starting from this point significant, life threatening, underlying reasons were found and treated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 31, 2006

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2013

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

6.4 years

First QC Date

March 6, 2017

Last Update Submit

April 2, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • The extreme significance of immediate investigation of cases of bilateral retinal emboli (non-diabetic bilateral posterior pole retinal nerve fiber or pre-retinal hemorrhages).

    Patients that are noticed to have signs of bilateral retinal emboli (bilateral retinal nerve fiber layer hemorrhages or bilateral pre-retinal hemorrhages and sometimes bilateral soft exudates) may be asymptomatic or have very mild symptoms. However these patients must be immediately and, if needed, intensively investigated to find the source of these emboli. The extremely important point of this study is these patients usually have life threatening conditions that should be found out and treated in time.

    through study completion, an average of one year

Interventions

imagingDIAGNOSTIC_TEST

imaging before and after treatment

Also known as: color fundus photos

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

any patient in which signs of bilateral retinal emboli are seen and documented (imaged).

You may qualify if:

  • any patient who is found to have sure signs of bilateral retinal emboli.

You may not qualify if:

  • all other bilateral retinal diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. S.S. Michel Clinic

Edmonton, Alberta, T5R5W9, Canada

Location

MeSH Terms

Interventions

Diagnostic Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • shawkat s. Michel, MD, FRCS Ed

    Dr. S.S. Michel Clinic, 214 MHC, 156 street and 87 Ave, Edmonton, AB, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 6, 2017

First Posted

March 13, 2017

Study Start

August 31, 2006

Primary Completion

January 29, 2013

Study Completion

December 31, 2018

Last Updated

April 4, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will share

Color photographs of patients with bilateral retinal emboli and relevant medical conditions will be shared.

Time Frame
Color photographs are available from the time of publishing and until the end of 2018.
Access Criteria
Ophthalmologists interested may request the color photos by mail or email. Within four weeks from receiving request color photos will be sent

Locations