Tracking Optical Coherence Tomography | NCT00343603

Studies
Tracking Optical Coherence Tomography

NCT00343603

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Oct 25, 2016Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Macular Degeneration
Glaucoma
Diabetic Retinopathy
Choroidal Disease

Interventions

Not provided

Countries

United States

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

ID	Type	Description	Link
2R44EY013036	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jul 2011

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

Oct 2004

Primary Completion Date

Dec 2010Actual

Completion Date

Jan 2011Actual

First Submitted Date

Jun 19, 2006

First Submission Date that Met QC Criteria

Jun 22, 2006

First Posted Date

Jun 23, 2006Estimated

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

Oct 24, 2016

Last Update Posted Date

Oct 25, 2016Estimated

Name	Class
National Eye Institute (NEI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this research study is to evaluate an investigational system that may allow doctors to show images of the different parts inside the eye that show greater detail than current equipment can produce.

Detailed Description

The purpose of this research study is to evaluate an investigational system that may allow doctors to make images of the parts inside the eye that show greater detail than current equipment can produce.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy individuals (this includes women of child-bearing potential) who are familiar with vision experiments and ophthalmic equipment, all over 18 years.
Subjects will have a retinal screening if they are over 50 years old or have a known risk factor for eye disease, such as family history of age related macular degeneration or cardiovascular disease.
Patients with retinal and choroidal disease: age related maculopathy or age related macular degeneration, diabetic retinopathy, glaucoma.

Exclusion Criteria:

Over 85 years old

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Subject can range between 18 to 85 years old. They can be healthy or diseased. Recruiting males and females.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gadi Wollstein, MD	University of Pittsburgh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pittsburgh		Pittsburgh	Pennsylvania	15213	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration
D005901	Glaucoma
D003930	Diabetic Retinopathy
D015862	Choroid Diseases

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases
D009798	Ocular Hypertension

Browse Leaves

Not provided

Browse Branches

Not provided