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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01027936

Enrollment

Registered

2009-12-09

Start date

2009-04-30

Completion date

2009-04-30

Last updated

2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy Volunteers

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results