- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03068702
New, Previously Unknown, Uses of Optical Coherence Tomography Angiography (OCTA) (OCTA)
March 1, 2017 updated by: Dr. Shawkat Michel, Dr. S.S. Michel Clinic
New, Previously Unknown, Uses of Optical Coherence Tomography Angiography (OCTA): Sickle Cell Maculopathy
Sickle cell maculopathy was sparingly mentioned in the literature before despite the fact that sickle cell disease or sickle cell trait is common in people of many areas of the world.
This study shows that OCTA is a very valuable, non invasive, office procedure that may well be used in diagnosing this disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
this is a clinical study of two African Canadian patients that were diagnosed with sickle cell trait.
I used OCTA to show macular vascular occlusions that usually happen with this disease.
Study Type
Observational
Enrollment (Actual)
2
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
African Canadian adults
Description
Inclusion Criteria: people with sickle cell trait or sickle cell disease -
Exclusion Criteria:
-
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
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
African Canadians
African Canadians with sickle cell disease maculopathy diagnosed by OCTA.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
vascular changes seen in the macular vasculature of people with sickle cell disease/ trait as compared to macular vasculature of normal macula.
Time Frame: through study completion, an average of one year
|
in this angiography the delicate vasculature of the macula can be clearly visualized and documented.
|
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
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 21, 2016
Primary Completion (Actual)
January 12, 2017
Study Completion (Actual)
February 21, 2017
Study Registration Dates
First Submitted
February 22, 2017
First Submitted That Met QC Criteria
March 1, 2017
First Posted (Actual)
March 3, 2017
Study Record Updates
Last Update Posted (Actual)
March 3, 2017
Last Update Submitted That Met QC Criteria
March 1, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Optical Coherence Tomography
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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