- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03460600
Vitreo-papillary Traction as an Entity Identified by Optical Coherence Tomography (OCT).
March 7, 2018 updated by: Dr. Shawkat Michel, Dr. S.S. Michel Clinic
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T5R 5W9
- Dr. S.S. Michel Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
any himan subject that is found to have VPT by OCT.
Description
Inclusion Criteria:
- any human subject that is found to have VPT by OCT.
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
through study completion, usually one day.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: shawkat michel, Dr. S.S. Michel Clinic Edmonton, Alberta Canada
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 27, 2018
Primary Completion (Actual)
February 28, 2018
Study Completion (Actual)
February 28, 2018
Study Registration Dates
First Submitted
February 28, 2018
First Submitted That Met QC Criteria
March 7, 2018
First Posted (Actual)
March 9, 2018
Study Record Updates
Last Update Posted (Actual)
March 9, 2018
Last Update Submitted That Met QC Criteria
March 7, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- vitreo-papillary traction
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
starting now for three months till May 31, 2018.
IPD Sharing Access Criteria
send a new USB and a postage paid return envelop.
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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