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Trial record 2 of 9 for:    sickle cell retinopathy

New, Previously Unknown, Uses of Optical Coherence Tomography Angiography (OCTA) (OCTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03068702
Recruitment Status : Completed
First Posted : March 3, 2017
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Shawkat Michel, Dr. S.S. Michel Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment
Sickle Cell Retinopathy Device: Optical Coherence Tomography Angiography

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.

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Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: New, Previously Unknown, Uses of Optical Coherence Tomography Angiography (OCTA): Sickle Cell Maculopathy
Actual Study Start Date : August 21, 2016
Actual Primary Completion Date : January 12, 2017
Actual Study Completion Date : February 21, 2017

Group/Cohort Intervention/treatment
African Canadians
African Canadians with sickle cell disease maculopathy diagnosed by OCTA.
Device: Optical Coherence Tomography Angiography



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
African Canadian adults
Criteria

Inclusion Criteria: people with sickle cell trait or sickle cell disease -

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068702


Sponsors and Collaborators
Dr. S.S. Michel Clinic
Investigators
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Principal Investigator: shawkat s Michel, MD, FRCS Ed Dr. S.S. Michel Clinic, 214 MHC, 156 street and 87 Ave, Edmonton, AB, Canada
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Responsible Party: Dr. Shawkat Michel, Principal Investigator, Dr. S.S. Michel Clinic
ClinicalTrials.gov Identifier: NCT03068702    
Other Study ID Numbers: Optical Coherence Tomography
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Retinal Diseases
Eye Diseases