Vitreo-papillary Traction as an Entity Identified by Opti... | NCT03460600

Studies
Vitreo-papillary Traction as an Entity Identified by Optical Coherence Tomography (OCT).

NCT03460600

Sponsor

Dr. S.S. Michel Clinic

Status

Completed

Last Update Posted

Mar 9, 2018Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Tomography, Optical Coherence

Interventions

Optical Coherence Tomography (OCT)

Countries

Canada

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

Mar 2018

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

Feb 27, 2018Actual

Primary Completion Date

Feb 28, 2018Actual

Completion Date

Feb 28, 2018Actual

First Submitted Date

Feb 28, 2018

First Submission Date that Met QC Criteria

Mar 7, 2018

First Posted Date

Mar 9, 2018Actual

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 7, 2018

Last Update Posted Date

Mar 9, 2018Actual

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

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.

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

1Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Optical Coherence Tomography (OCT)	Other	Optical Coherence Tomography is a fairly new imaging technique in ophthalmology

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	through study completion, usually one day.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

any human subject that is found to have VPT by OCT.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

any himan subject that is found to have VPT by OCT.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
shawkat michel	Dr. S.S. Michel Clinic Edmonton, Alberta Canada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. S.S. Michel Clinic		Edmonton	Alberta	T5R 5W9	Canada

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Clinical Study Report (CSR)

Time Frame

starting now for three months till May 31, 2018.

Access Criteria

send a new USB and a postage paid return envelop.

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D041623	Tomography, Optical Coherence

Ancestor Terms

ID	Term
D041622	Tomography, Optical
D061848	Optical Imaging
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided