GlaucomaNCT02050880
OCT Agreement and Crossed Precision Study
An observational study of Glaucoma and Retinal Disease, run by Nidek Co. LTD. at 1 site in United States.
Trial summary
The purpose of this study is to asses the agreement of the RS-3000 Lite and RS-3000 Advance to the RS-3000, assess the crossed precision of each study device and to assess the transference of a reference database from the RS-3000 to the RS-3000 Lite and to the RS-3000 Advance. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Retinal Disease, Corneal Disease
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jun 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: Clinic subjects, general population
Who may be able to join
- Subjects who do not have pathology in both eyes
- Subjects who have a glaucoma diagnosis
- Subjects who have a retinal diagnosis including but not limited to:
- Diabetic macular edema
- Dry age related macular degeneration
- Wet age related macular degeneration
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- Cystoid macular edema
- Epiretinal membrane
- Macular hole
- Subjects who has one of these diagnosis:
- Post status LASIK surgery
- Keratoconus
- Other corneal dystrophies or degenerations.
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
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- A history of, or currently receiving, anticancer therapy
- Epileptic seizures which are optically induced
- Dementia
- Subjects who have other life threatening and debilitating systemic diseases
- Note: Additional criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
WCCT Global Opthalmology Research Center
Santa Ana, California, 92705
About this study
Official title: Crossed Precision Design Study of the Nidek Optical Coherence Tomography RS-3000, RS-3000 Lite and RS-3000 Advance for the Measurements of Retinal and RNFL Thickness, Optic Disc Analysis, and Pachymetry
The purpose of this study is to asses the agreement of the RS-3000 Lite and RS-3000 Advance to the RS-3000, assess the crossed precision of each study device and to assess the transference of a reference database from the RS-3000 to the RS-3000 Lite and to the RS-3000 Advance.
- Conditions
- Glaucoma, Retinal Disease, Corneal Disease
- Keywords
- Normal Eyes, Eye; Disorder with Glaucoma, Eye; Disorder with Retinal Disease, Eye; Disorder Corneal Disease incl kerato-refractive group
- Medical subject headings
- Glaucoma, Retinal Diseases, Corneal Diseases
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 eyes | Eyes without pathology. | |
| Glaucoma | Eyes with Glaucoma. | |
| Retinal | Eyes with Retinal Disease. | |
| Corneal | Eyes with corneal disease including a kerato-refractive group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal thickness
Time frame is the maximum duration of hospital stay
Measured: Approximately four hours
Optic Disc Analysis
Time frame is the maximum duration of hospital stay
Measured: Approximately four hours
Corneal Thickness
Time frame is the maximum duration of hospital stay
Measured: Approximately four hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- 119 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
- NCT02050880
- Sponsor's protocol ID
- RS-3000 series Protocol 1
- Status last verified
- Sep 2014
- First submitted
- 22 Jan 2014
- Last updated
- 29 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crossed Precision Design Study of the Nidek Optical Coherence Tomography RS-3000, RS-3000 Lite and RS-3000 Advance for the Measurements of Retinal and RNFL Thickness, Optic Disc Analysis, and Pachymetry
- ClinicalTrials.gov ID
- NCT02050880
- Acronym / sponsor ID
- RS-3000 series Protocol 1
- Conditions
- Glaucoma, Retinal Disease, Corneal Disease
- Keywords
- Normal Eyes, Eye; Disorder with Glaucoma, Eye; Disorder with Retinal Disease, Eye; Disorder Corneal Disease incl kerato-refractive group
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Nidek Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 31 Jan 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 purpose of this study is to asses the agreement of the RS-3000 Lite and RS-3000 Advance to the RS-3000, assess the crossed precision of each study device and to assess the transference of a reference database from the RS-3000 to the RS-3000 Lite and to the RS-3000 Advance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal eyes | – | –Eyes without pathology. |
| Glaucoma | – | –Eyes with Glaucoma. |
| Retinal | – | –Eyes with Retinal Disease. |
| Corneal | – | –Eyes with corneal disease including a kerato-refractive group. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Clinic subjects, general population
Key inclusion criteria (13 listed)
- Subjects who do not have pathology in both eyes
- Subjects who have a glaucoma diagnosis
- Subjects who have a retinal diagnosis including but not limited to:
- Subjects who has one of these diagnosis:
Key exclusion criteria (11 listed)
- Subjects who have any of the following conditions
- Subjects who have other life threatening and debilitating systemic diseases
- Note: Additional criteria may apply
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
Retinal thickness
Time frame: Approximately four hours
Time frame is the maximum duration of hospital stay
Optic Disc Analysis
Time frame: Approximately four hours
Time frame is the maximum duration of hospital stay
Corneal Thickness
Time frame: Approximately four hours
Time frame is the maximum duration of hospital stay
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 29 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 Glaucoma and Retinal Disease, run by Nidek Co. LTD. at 1 site 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 13 inclusion and 11 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 29 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 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?
Retinal thickness (time frame: Approximately four hours). The study lists 3 primary outcomes in all. 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 29 Sep 2014.