An Age-Stratified Data Collection Study in Adult Males and Females, Ages 18 and Above to Establish a Normative Database Using the 3D Optical Coherence Tomography 3D OCT-1000 Mark II

Healthy Clinical Trial

Official title:

An Age-Stratified Data Collection Study in Adult Males and Females, Ages 18 and Above to Establish a Normative Database Using the 3D Optical Coherence Tomography 3D OCT-1000 Mark II

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01027936
• Other study ID #: NDB-001
• Status: Active, not recruiting
• Phase: Phase 4
• First received: December 8, 2009
• Last updated: November 8, 2010
• Start date: April 2009
• Est. completion date: November 2010

Study information

• Verified date: November 2010
• Source: Topcon Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: November 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
United States	Shiley Eye Center UCSD	La Jolla	California
United States	Eye Institute/Medical College of WI	Milwaukee	Wisconsin
United States	Glaucoma Associates of New York	New York	New York
United States	SUNY	New York	New York
United States	Vitreous-Retina-Macula Consultants of New York, P.C.	New York	New York
United States	Durrie Vision	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Topcon Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No