Tomography, Optical CoherenceNCT03460600
Vitreo-papillary Traction as an Entity Identified by Optical Coherence Tomography (OCT).
An observational study of Tomography, Optical Coherence, run by Dr. S.S. Michel Clinic at 1 site in Canada.
Trial summary
Optical Coherence Tomography (OCT) is a relatively new imaging technique in ophthalmology. This clear and documented imaging identified new diseases/ observations that were not previously known. Read more about this study
- Who is it for?
- Ages 40 to 90 years, men only
- Conditions the study is for
- Tomography, Optical Coherence
- What is being tested?
- Optical Coherence Tomography (OCT)
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- 27 Feb 2018to 28 Feb 2018
- 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 40 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: any himan subject that is found to have VPT by OCT.
Who may be able to join
- any human subject that is found to have VPT by OCT.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OCT Documents Vitreo-papillary Traction
Optical Coherence Tomography (OCT) is a relatively new imaging technique in ophthalmology. This clear and documented imaging identified new diseases/ observations that were not previously known.
Read the detailed description
In ophthalmology vitreo-macular adhesion, vitreo-macular traction and posterior vitreous detachment were recognized entities for a long time. On the other hand vitreo-papillary adhesion/ traction is a fairly new concept in ophthalmology that became known after the use of OCT in ophthalmology imaging. Reasons, effects and ways of treatment of vitreo-papillary traction will take some time to evolve. The case study in which this traction was documented was initiated by an observation of a persistent, tiny single retinal hemorrhage above the optic disc of an eye. The patient was completely asymptomatic because of the vitreo-papillary traction but the OCT documentation of the case was so clear and striking.
- Conditions
- Tomography, Optical Coherence
- Being tested
- Optical Coherence Tomography (OCT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography (OCT)Other
Optical Coherence Tomography is a fairly new imaging technique in ophthalmology
What is being measured
The primary outcome is the main question the study is designed to answer.
Tomography, Optical Coherence (OCT)
Vitreo-papillary traction (VPT) is a relatively new finding in ophthalmology that became very well known and documented by Optical Coherence Tomography (OCT)
Measured: through study completion, usually one day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start27 Feb 2018
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tomography, Optical CoherenceStudies 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
- 1 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 michel, Principal investigator, Dr. S.S. Michel Clinic Edmonton, Alberta Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460600
- Sponsor's protocol ID
- vitreo-papillary traction
- Status last verified
- Mar 2018
- First submitted
- 28 Feb 2018
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: if someone is interested in this case he/ she needs to send a new/ previously unused USB and I will transfer OCT images available to him/ her.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCT Documents Vitreo-papillary Traction
- ClinicalTrials.gov ID
- NCT03460600
- Acronym / sponsor ID
- vitreo-papillary traction
- Conditions
- Tomography, Optical Coherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Dr. S.S. Michel ClinicUniversity, hospital or other
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 9 Mar 2018 (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.
Optical Coherence Tomography (OCT) is a relatively new imaging technique in ophthalmology. This clear and documented imaging identified new diseases/ observations that were not previously known.
Detailed description
In ophthalmology vitreo-macular adhesion, vitreo-macular traction and posterior vitreous detachment were recognized entities for a long time. On the other hand vitreo-papillary adhesion/ traction is a fairly new concept in ophthalmology that became known after the use of OCT in ophthalmology imaging. Reasons, effects and ways of treatment of vitreo-papillary traction will take some time to evolve. The case study in which this traction was documented was initiated by an observation of a persistent, tiny single retinal hemorrhage above the optic disc of an eye. The patient was completely asymptomatic because of the vitreo-papillary traction but the OCT documentation of the case was so clear and striking.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- any himan subject that is found to have VPT by OCT.
Key inclusion criteria (1 listed)
- any human subject that is found to have VPT by OCT.
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 (OCT)Optical Coherence Tomography is a fairly new imaging technique in ophthalmology | Other | – |
Primary outcome
Tomography, Optical Coherence (OCT)
Time frame: through study completion, usually one day.
Vitreo-papillary traction (VPT) is a relatively new finding in ophthalmology that became very well known and documented by Optical Coherence Tomography (OCT)
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 9 Mar 2018.
- Individual participant dataSharing planned: Yes. if someone is interested in this case he/ she needs to send a new/ previously unused USB and I will transfer OCT images available to him/ her.
Related trials for Tomography, Optical Coherence
Active, not recruiting
Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS
Coronary Artery Disease, Coronary Disease
RecruitingObservational study
The Value of Measuring Retinal Vascular Density by Optical Coherence Tomography-Angiography (OCT-A) in Patients With Microvascular Angina Confirmed by Myocardial Microcirculatory Resistance Index (MRI).
Microvascular Angina
Active, not recruitingObservational study
Assessment of NfL and GFAP Levels, Atrophy of the Macula GCC by OCT and Whole Brain Atrophy by MRI to Predict Evolution of Neurological Disability in MS Patients
Multiple Sclerosis
Not yet recruiting
Rapid Inflation/Deflation Compared With Prolonged High-Pressure Balloon Inflation
Coronary Artery Disease, Coronary Stent Occlusion
Not yet recruiting
Optical Coherence Tomography-Assisted Strategy for Interventional Management of Symptomatic Carotid Stenosis (OASIS-C)
Carotid Stenosis
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 michel principal investigator
Dr. S.S. Michel Clinic Edmonton, Alberta Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tomography, Optical Coherence, run by Dr. S.S. Michel Clinic at 1 site in Canada.
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 1 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 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Tomography, Optical Coherence (OCT) (time frame: through study completion, usually one day.). 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 9 Mar 2018.