HealthyNCT02198560
RS-3000 Lite Agreement Study
An observational study of Healthy, run by Nidek Co. LTD. at 1 site in Japan.
Trial summary
The primary objectives of the study are to assess the agreement between the two different scan mode of the RS-3000 Lite. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- RS-3000 Lite
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2014to Aug 2014
- 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 (Eyes without pathology)
Who may be able to join
- Subjects who do not have pathology in both eyes
Who cannot join
- Subjects who have any of the following conditions:
- Diabetes mellitus (DM) and/or diabetic retinopathy
- Uncontrolled Hypertension (HT)
- Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision
- Cardiac, hepatic, renal and hematologic diseases
- A current condition requiring systemic administration of steroid
Show all 10Show fewer
- A history of, or currently receiving, anticancer therapy
- Epileptic seizures which are optically induced
- Dementia
- Note: Additional criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
The primary objectives of the study are to assess the agreement between the two different scan mode of the RS-3000 Lite.
- Conditions
- Healthy
- Being tested
- RS-3000 Lite
- Keywords
- Normal (Eyes without pathologies)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RS-3000 LiteDevice
| Study group | Role | What they receive |
|---|---|---|
| Normal (Eyes without pathology) | Not described Receives: Device: RS-3000 Lite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal thickness and Optic Disc Analysis
Time frame is the maximum duration of hospital stay.
Measured: 3 hours
Secondary outcomes (1)
Number of participants with adverse events
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2014
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nidek Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198560
- Sponsor's protocol ID
- NRL-1
- Status last verified
- Sep 2014
- First submitted
- 17 Jul 2014
- Last updated
- 11 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RS-3000 Lite Agreement Study
- ClinicalTrials.gov ID
- NCT02198560
- Acronym / sponsor ID
- NRL-1
- Conditions
- Healthy
- Keywords
- Normal (Eyes without pathologies)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nidek Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Aug 2014 (actual)
- First posted
- 23 Jul 2014 (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 primary objectives of the study are to assess the agreement between the two different scan mode of the RS-3000 Lite.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal (Eyes without pathology) | – | Device: RS-3000 Lite |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal (Eyes without pathology)
Key inclusion criteria (1 listed)
- Subjects who do not have pathology in both eyes
Key exclusion criteria (10 listed)
- Diabetes mellitus (DM) and/or diabetic retinopathy
- Uncontrolled Hypertension (HT)
- Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision
- Cardiac, hepatic, renal and hematologic diseases
- A current condition requiring systemic administration of steroid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RS-3000 Lite | Device | Normal (Eyes without pathology) |
Primary outcome
Retinal thickness and Optic Disc Analysis
Time frame: 3 hours
Time frame is the maximum duration of hospital stay.
1 secondary outcome
Number of participants with adverse events
Time frame: 1day
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 11 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Nidek Co. LTD. at 1 site in Japan.
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 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: finished, as of the sponsor's last update on 11 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
Retinal thickness and Optic Disc Analysis (time frame: 3 hours). 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 11 Sep 2014.