Sickle Cell RetinopathyOCTANCT03068702
New, Previously Unknown, Uses of Optical Coherence Tomography Angiography (OCTA)
An observational study of Sickle Cell Retinopathy, run by Dr. S.S. Michel Clinic.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sickle Cell Retinopathy
- What is being tested?
- Optical Coherence Tomography Angiography
- Type of treatment
- Medical device
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 21 Aug 2016to 21 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: African Canadian adults
Who may be able to join
None listed.
Who cannot join
- -
About this study
Official title: 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.
Read the 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.
- Conditions
- Sickle Cell Retinopathy
- Being tested
- Optical Coherence Tomography Angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography AngiographyDevice
| Study group | Role | What they receive |
|---|---|---|
| African Canadians | African Canadians with sickle cell disease maculopathy diagnosed by OCTA. Receives: Device: Optical Coherence Tomography Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start21 Aug 2016
- Primary completion12 Jan 2017
- Study completion21 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. S.S. Michel Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Shawkat Michel, Dr. S.S. Michel Clinic
- Investigators
- shawkat s Michel, MD, FRCS Ed, Principal investigator, Dr. S.S. Michel Clinic, 214 MHC, 156 street and 87 Ave, Edmonton, AB, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068702
- Sponsor's protocol ID
- Optical Coherence Tomography
- Acronym
- OCTA
- Status last verified
- Feb 2017
- First submitted
- 22 Feb 2017
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New, Previously Unknown, Uses of Optical Coherence Tomography Angiography (OCTA): Sickle Cell Maculopathy
- ClinicalTrials.gov ID
- NCT03068702
- Acronym / sponsor ID
- OCTA / Optical Coherence Tomography
- Conditions
- Sickle Cell Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Dr. S.S. Michel ClinicUniversity, hospital or other
- Study start
- 21 Aug 2016 (actual)
- Primary completion
- 12 Jan 2017 (actual)
- Study completion
- 21 Feb 2017 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| African Canadians | – | Device: Optical Coherence Tomography AngiographyAfrican Canadians with sickle cell disease maculopathy diagnosed by OCTA. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- African Canadian adults
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical Coherence Tomography Angiography | Device | African Canadians |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
shawkat s Michel, MD, FRCS Ed principal investigator
Dr. S.S. Michel Clinic, 214 MHC, 156 street and 87 Ave, Edmonton, AB, Canada
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Retinopathy, run by Dr. S.S. Michel Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.