New, Previously Unknown, Uses of Optical Coherence Tomogr... | NCT03068702

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

NCT03068702

Sponsor

Dr. S.S. Michel Clinic

Status

Completed

Last Update Posted

Mar 3, 2017Actual

Enrollment

2Actual

Phase

Not provided

Conditions

Sickle Cell Retinopathy

Interventions

Optical Coherence Tomography Angiography

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 21, 2016Actual

Primary Completion Date

Jan 12, 2017Actual

Completion Date

Feb 21, 2017Actual

First Submitted Date

Feb 22, 2017

First Submission Date that Met QC Criteria

Mar 1, 2017

First Posted Date

Mar 3, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2017

Last Update Posted Date

Mar 3, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
African Canadians		African Canadians with sickle cell disease maculopathy diagnosed by OCTA.	Device: Optical Coherence Tomography Angiography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Optical Coherence Tomography Angiography	Device		African Canadians

Outcomes Module

Primary Outcomes

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.	in this angiography the delicate vasculature of the macula can be clearly visualized and documented.	through study completion, an average of one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

African Canadian adults

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided