Ocular PhysiologyNCT01663688
Data Collection Study of the Nidek Optical Coherence Tomography RS-3000 for 3D Measurements of the Eye
An observational study of Ocular Physiology, run by Nidek Co. LTD. at 3 sites in United States.
Trial summary
The purpose of this clinical study is to collect and evaluate the data from eye scans using an investigational three-dimensional eye imaging photography device called the Nidek Optical Coherence Tomography (OCT) RS-3000. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ocular Physiology
- How many people
- 279 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2012to Aug 2013
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal subject eyes
Who may be able to join
- Normal and healthy male and female subjects at least 20 years of age.
Who cannot join
- Subjects who have extensive or debilitating systemic diseases.
- Subjects who have significant ocular disease.
- Subjects who are extremely far sighted or extremely near sighted.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UC San Diego, Hamilton Glaucoma Center, Department of Ophthalmology
La Jolla, California, 92093
USC Eye Institute, Keck Medical Center of USC
Los Angeles, California, 90033
UC Davis, Medical Center, Department of Ophthalmology & Vision Science
Sacramento, California, 95817
About this study
Official title: Normative Data Collection Study of the Nidek Optical Coherence Tomography RS-3000 for the Measurements of Retinal and RNFL Thickness and Optic Disc Analysis
The purpose of this clinical study is to collect and evaluate the data from eye scans using an investigational three-dimensional eye imaging photography device called the Nidek Optical Coherence Tomography (OCT) RS-3000. OCT stands for Optical Coherence Tomography, a technique that uses invisible wavelengths of light to make detailed images of the tissues at the back of the eye. These images provide information that physicians may use to help diagnose eye conditions and/or to monitor changes in the eye during treatment.
Read the detailed description
This is a prospective, open-labeled, multi-center clinical study. After qualifying examination of a subject, 3D retinal measurement in the proximity of the optic disc and the macula are carried out for eligible subjects with normal eyes using an investigational three-dimensional eye imaging photography device called the Nidek Optical Coherence Tomography (OCT) RS-3000. The primary objective of this clinical study is to develop age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer (RNFL) etc. using the Nidek Optical Coherence Tomography (OCT) RS-3000 with normative database. The secondary objective is to evaluate any adverse events found during the clinical study.
- Conditions
- Ocular Physiology
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 |
|---|---|---|
| Normative Data Collection | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer (RNFL) and Optic Disc Analysis
The primary objective of this clinical study is to develop age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer (RNFL)and Optic Disc Analysis.
Measured: Subjects will be followed for the duration of the procedure, up to one day.
Secondary outcomes (1)
Evaluation of adverse events found during the clinical study
The secondary objective is to evaluate any adverse events found during the clinical study.
Measured: Subjects will be followed for the duration of the procedure, up to one day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular PhysiologyStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nidek Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert N Weinreb, MD, Principal investigator, Hamilton Glaucoma Center, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663688
- Sponsor's protocol ID
- OCT RS-3000
- Status last verified
- Jan 2014
- First submitted
- 12 Jul 2012
- Last updated
- 20 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normative Data Collection Study of the Nidek Optical Coherence Tomography RS-3000 for the Measurements of Retinal and RNFL Thickness and Optic Disc Analysis
- ClinicalTrials.gov ID
- NCT01663688
- Acronym / sponsor ID
- OCT RS-3000
- Conditions
- Ocular Physiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Nidek Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 13 Aug 2012 (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.
The purpose of this clinical study is to collect and evaluate the data from eye scans using an investigational three-dimensional eye imaging photography device called the Nidek Optical Coherence Tomography (OCT) RS-3000. OCT stands for Optical Coherence Tomography, a technique that uses invisible wavelengths of light to make detailed images of the tissues at the back of the eye. These images provide information that physicians may use to help diagnose eye conditions and/or to monitor changes in the eye during treatment.
Detailed description
This is a prospective, open-labeled, multi-center clinical study. After qualifying examination of a subject, 3D retinal measurement in the proximity of the optic disc and the macula are carried out for eligible subjects with normal eyes using an investigational three-dimensional eye imaging photography device called the Nidek Optical Coherence Tomography (OCT) RS-3000. The primary objective of this clinical study is to develop age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer (RNFL) etc. using the Nidek Optical Coherence Tomography (OCT) RS-3000 with normative database. The secondary objective is to evaluate any adverse events found during the clinical study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normative Data Collection | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal subject eyes
Key inclusion criteria (1 listed)
- Normal and healthy male and female subjects at least 20 years of age.
Key exclusion criteria (3 listed)
- Subjects who have extensive or debilitating systemic diseases.
- Subjects who have significant ocular disease.
- Subjects who are extremely far sighted or extremely near sighted.
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
Development of age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer (RNFL) and Optic Disc Analysis
Time frame: Subjects will be followed for the duration of the procedure, up to one day.
The primary objective of this clinical study is to develop age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer (RNFL)and Optic Disc Analysis.
1 secondary outcome
Evaluation of adverse events found during the clinical study
Time frame: Subjects will be followed for the duration of the procedure, up to one day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2014.
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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 N Weinreb, MD principal investigator
Hamilton Glaucoma Center, UC San Diego
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ocular Physiology, run by Nidek Co. LTD. at 3 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 20 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Development of age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer (RNFL) and Optic Disc Analysis (time frame: Subjects will be followed for the duration of the procedure, up to one day.). 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 20 Jan 2014.