The Extreme Significance of Bilateral Embolic Retinal Phenomena That Can be Life Saving

April 2, 2019 updated by: Dr. Shawkat Michel

Bilateral Retinal Embolic Phenomena Always Necessitates Immediate and Intensive Investigation. Careful, Documented, Ophthalmic Examination is All we Require to Initiate Life Saving Investigations.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Two patients were found to have signs of simultaneous bilateral retinal emboli. One patient was asymptomatic and routine ophthalmic examination showed bilateral retinal hemorrhages and exudates close to both optic discs. This patient was on anti-coagulant treatment for atrial fibrillation. The finding of bilateral signs of retinal emboli necessitated immediate blood tests and dose adjustments of her medication.

The second case did not have general symptoms other than mild evening chills and her eye examination again was the start point of intensive investigation to find the reason of her bilateral retinal emboli. Ultrasound studies revealed a life threatening reason that was urgently treated.

Study Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5R5W9
        • Dr. S.S. Michel Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • all other bilateral retinal diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The extreme significance of immediate investigation of cases of bilateral retinal emboli (non-diabetic bilateral posterior pole retinal nerve fiber or pre-retinal hemorrhages).
Time Frame: through study completion, an average of one year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Shawkat Michel

Investigators

  • Principal Investigator: shawkat s. Michel, MD, FRCS Ed, Dr. S.S. Michel Clinic, 214 MHC, 156 street and 87 Ave, Edmonton, AB, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2006

Primary Completion (Actual)

January 29, 2013

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

March 6, 2017

First Submitted That Met QC Criteria

March 8, 2017

First Posted (Actual)

March 13, 2017

Study Record Updates

Last Update Posted (Actual)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Bilateral retinal emboli

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Color photographs are available from the time of publishing and until the end of 2018.

IPD Sharing Access Criteria

Ophthalmologists interested may request the color photos by mail or email. Within four weeks from receiving request color photos will be sent

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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