HealthyNCT01027936
An Age-Stratified Data Collection Study to Establish a Normative Database Using the 3D Optical Coherence Tomography 3D OCT-1000 Mark II
An observational study of Healthy, run by Topcon Corporation at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 0 participants
- Where
- 6 sitesUnited States
- Study dates
- 30 Apr 2009to 30 Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 180 male and female volunteers from 6 centers with normal, healthy eyes form six age groups, aged 18 years or older.
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Shiley Eye Center UCSD
La Jolla, California, 92037
Eye Institute/Medical College of WI
Milwaukee, Wisconsin, 53226
Glaucoma Associates of New York
New York, New York, 10003
Vitreous-Retina-Macula Consultants of New York, P.C.
New York, New York, 10022
SUNY
New York, New York, 10036
Durrie Vision
Overland Park, Kansas, 66211
About this study
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
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal Healthy Volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
A normative dataset containing a statistical description of expected norms of retinal nerve fiber layer (RNFL) and macula lutea thickness, stratified by age.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study start30 Apr 2009
- Primary completion30 Apr 2009
- Study completion30 Apr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Topcon Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Weinreb, M.D., Study director, University of California, San Diego; Shiley Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027936
- Sponsor's protocol ID
- NDB-001
- Status last verified
- Jul 2022
- First submitted
- 8 Dec 2009
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01027936
- Acronym / sponsor ID
- NDB-001
- Conditions
- Healthy
- Keywords
- Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Topcon CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2009 (actual)
- Primary completion
- 30 Apr 2009 (actual)
- Study completion
- 30 Apr 2009 (actual)
- First posted
- 9 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal Healthy Volunteers | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 180 male and female volunteers from 6 centers with normal, healthy eyes form six age groups, aged 18 years or older.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A normative dataset containing a statistical description of expected norms of retinal nerve fiber layer (RNFL) and macula lutea thickness, stratified by age.
Time frame: 12 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Weinreb, M.D. study director
University of California, San Diego; Shiley Eye Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Topcon Corporation at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A normative dataset containing a statistical description of expected norms of retinal nerve fiber layer (RNFL) and macula lutea thickness, stratified by age. (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.