An Age-Stratified Data Collection Study to Establish a Normative Database Using the 3D Optical Coherence Tomography 3D OCT-1000 Mark II

NCT01027936 | Withdrawn

• 1 other identifier: NDB-001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 6

Brief Summary

To collect three dimensional retinal measurements of the optic disc and the macula lutea on healthy normal subjects using the 3D OCT-1000 Mark II for the purpose of developing a normative database that is stratified by age.

Conditions

Healthy

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• A normative dataset containing a statistical description of expected norms of retinal nerve fiber layer (RNFL) and macula lutea thickness, stratified by age.

  12 Months

Study Arms (1)

Normal Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

180 male and female volunteers from 6 centers with normal, healthy eyes form six age groups, aged 18 years or older.

You may qualify if:

• Male and Females at least 18 years of age;
• 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.

You may not qualify if:

• Ocular disease;
• 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.

Sponsors & Collaborators

• Topcon Corporation: lead

Study Sites (6)

Shiley Eye Center UCSD

La Jolla, California, 92037, United States

Location

Durrie Vision

Overland Park, Kansas, 66211, United States

Location

Glaucoma Associates of New York

New York, New York, 10003, United States

Location

Vitreous-Retina-Macula Consultants of New York, P.C.

New York, New York, 10022, United States

Location

SUNY

New York, New York, 10036, United States

Location

Eye Institute/Medical College of WI

Milwaukee, Wisconsin, 53226, United States

Location

Study Officials

• Robert Weinreb, M.D.

  University of California, San Diego; Shiley Eye Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2009
• First Posted: December 9, 2009
• Study Start: April 30, 2009
• Primary Completion: April 30, 2009
• Study Completion: April 30, 2009
• Last Updated: December 13, 2024

Record last verified: 2022-07

Locations

US (6)