NCT03068702

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.

Trial Health

100
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 2016

Shorter than P25 for all trials

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 21, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 22, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
Last Updated

March 3, 2017

Status Verified

February 1, 2017

Enrollment Period

5 months

First QC Date

February 22, 2017

Last Update Submit

March 1, 2017

Conditions

Sickle Cell Retinopathy

Outcome Measures

Primary Outcomes (1)

  • vascular changes seen in the macular vasculature of people with sickle cell disease/ trait as compared to macular vasculature of normal macula.

    in this angiography the delicate vasculature of the macula can be clearly visualized and documented.

    through study completion, an average of one year

Study Arms (1)

African Canadians

African Canadians with sickle cell disease maculopathy diagnosed by OCTA.

Device: Optical Coherence Tomography Angiography

Interventions

Optical Coherence Tomography AngiographyDEVICE
African Canadians

Eligibility Criteria

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

African Canadian adults

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 22, 2017

First Posted

March 3, 2017

Study Start

August 21, 2016

Primary Completion

January 12, 2017

Study Completion

February 21, 2017

Last Updated

March 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share