An Age-Stratified Data Collection Study to Establish a Normative Database Using the 3D Optical Coherence Tomography 3D OCT-1000 Mark II
NCT ID: NCT01027936
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
OBSERVATIONAL
2009-04-30
2009-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Normal Healthy Volunteers
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Must be a member of one of the 3 ethnic groups: Caucasian, Hispanic or African American. Asians, Eastern Indians, and Native Americans have been excluded from this study;
* Signed, written informed consent obtained for the study;
* BSCVA of 20/40 or better in both eyes;
* Intraocular pressure (IOP) ≤ 21 mm Hg in both eyes.
Exclusion Criteria
* Cataract on slit lamp exam with a corresponding loss of BSCVA worse than 20/25;
* Corneal surface disruption precluding imaging;
* Prior ocular surgery except uncomplicated phacoemulsification or strabismus surgery;
* Prior corneal refractive surgery of any type;
* Family history of glaucoma among first generation relatives;
* Current history of an acute or chronic disease or illness that would confound the normative outcome(s) of the study;
* Current use of systemic medications that may confound the outcome of the study;
* Nystagmus or any other condition that would prevent a steady gaze during study tests or measurements;
* Current history of inflammation or infection of the eye or eyelids; injury to the eye.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Topcon Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert Weinreb, M.D.
Role: STUDY_DIRECTOR
University of California, San Diego; Shiley Eye Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Shiley Eye Center UCSD
La Jolla, California, United States
Durrie Vision
Overland Park, Kansas, United States
Glaucoma Associates of New York
New York, New York, United States
Vitreous-Retina-Macula Consultants of New York, P.C.
New York, New York, United States
SUNY
New York, New York, United States
Eye Institute/Medical College of WI
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NDB-001
Identifier Type: -
Identifier Source: org_study_id