Clinical trial NCT01027936: An Age-Stratified Data Collection Study to Establish a Normative Database Using the 3D Optical Coherence Tomography 3D OCT-1000 Mark II
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Healthy
Keywords: Healthy Volunteers
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2009-12-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: A normative dataset containing a statistical description of expected norms of retinal nerve fiber layer (RNFL) and macula lutea thickness, stratified by age.
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Shiley Eye Center UCSD
state: California
city: Overland Park
country: United States
facility: Durrie Vision
state: Kansas
city: New York
country: United States
facility: Glaucoma Associates of New York
state: New York
city: New York
country: United States
facility: Vitreous-Retina-Macula Consultants of New York, P.C.
state: New York
city: New York
country: United States
facility: SUNY
state: New York
city: Milwaukee
country: United States
facility: Eye Institute/Medical College of WI
state: Wisconsin
Study officials:
affiliation: University of California, San Diego; Shiley Eye Center
name: Robert Weinreb, M.D.
role: STUDY_DIRECTOR
References: