Retinal DiseaseNCT00792259
Topcon 3D OCT-1000 Optical Coherence Tomography System
An observational study of Retinal Disease and Glaucoma, run by Topcon Medical Systems, Inc. at 4 sites in United States.
Trial summary
The purpose of this clinical protocol is to perform a comparison of Retinal and Retinal Nerve Fiber Layer (RNFL) thickness measurements between the Topcon 3D-1000 and the identified predicate device. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinal Disease, Glaucoma
- How many people
- 48 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2008to Nov 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ophthalmology practice
Who may be able to join
- Male or female
- Between 18 and 80 years of age
- Either eye, but only one eye per subject will be enrolled
- Topcon image quality factor ≥ 45 or Stratus signal strength ≥ 5.
- Male or female
- Between 18 and 80 years of age
Show all 10Show fewer
- Either eye, but only one eye per subject will be enrolled
- Symptoms consistent with one of the following retinal diseases: diabetic macular edema, cystoid macular edema, epiretinal membrane, macular hole, wet AMD and dry AMD for which OCT imaging is warranted. At lease one (1) case each of these diseases will be included in the study
- A range of retinal thickness will be included
- Topcon image quality factor ≥ 45 or Stratus signal strength ≥ 5.
Who cannot join
- Any known ocular disease
- Any systemic disease that could result in ocular manifestations such as hypertension, diabetes, heart disease, etc.
- Topcon image quality factor ≤ 44 or Stratus signal strength < 5.
- Retinal Disease
- Presence of glaucoma
- Topcon image quality factor ≤ 44 or Stratus signal strength < 5.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Retina Consultations
Bronxville, New York, 10708
New York Eye and Ear-Glaucoma Associates of New York
New York, New York, 10003
Vitreous-Retina-Macula Consultants of NY
New York, New York, 10022
SUNY
New York, New York, 10036
About this study
Official title: Topcon 3D OCT-1000 Optical Coherence Tomography System for Measurements of Retinal and RNFL Thicknesses: Precision and Agreement Study
The purpose of this clinical protocol is to perform a comparison of Retinal and Retinal Nerve Fiber Layer (RNFL) thickness measurements between the Topcon 3D-1000 and the identified predicate device. In addition, this protocol performs a comparison of the thickness measurement results from images collected and analyzed with the Zeiss Stratus OCT to images collected with the Zeiss Stratus OCT and imported into the Topcon 3D OCT-1000 StratusViewer for analysis.
- Conditions
- Retinal Disease, Glaucoma
- Medical subject headings
- Retinal Diseases, Glaucoma
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 |
|---|---|---|
| 1 | Patients with Retinal Disease | |
| 2 | Patients without Retinal Disease | |
| 3 | Normal Subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device
The precision and agreement measures the thickness of RNFL and Full Retinal Thickness of the study device and is compared to the predicate device to show agreement.
Keywords, ILM - Internal Limiting Membrane RPE - Retinal Pigment Epithelium RNFL - Retinal Nerve Fiber Layer
Measured: 30 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Retinal DiseaseStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Topcon Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792259
- Sponsor's protocol ID
- Topcon 01
- Status last verified
- Jun 2022
- First submitted
- 14 Nov 2008
- Last updated
- 28 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topcon 3D OCT-1000 Optical Coherence Tomography System for Measurements of Retinal and RNFL Thicknesses: Precision and Agreement Study
- ClinicalTrials.gov ID
- NCT00792259
- Acronym / sponsor ID
- Topcon 01
- Conditions
- Retinal Disease, Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Topcon Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 17 Nov 2008 (estimated)
- Results
- Posted 17 Jun 2015
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 protocol is to perform a comparison of Retinal and Retinal Nerve Fiber Layer (RNFL) thickness measurements between the Topcon 3D-1000 and the identified predicate device. In addition, this protocol performs a comparison of the thickness measurement results from images collected and analyzed with the Zeiss Stratus OCT to images collected with the Zeiss Stratus OCT and imported into the Topcon 3D OCT-1000 StratusViewer for analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with Retinal Disease |
| 2 | – | –Patients without Retinal Disease |
| 3 | – | –Normal Subjects |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ophthalmology practice
Key inclusion criteria (10 listed)
- Male or female
- Between 18 and 80 years of age
- Either eye, but only one eye per subject will be enrolled
- Topcon image quality factor ≥ 45 or Stratus signal strength ≥ 5.
- Male or female
Key exclusion criteria (6 listed)
- Any known ocular disease
- Any systemic disease that could result in ocular manifestations such as hypertension, diabetes, heart disease, etc.
- Topcon image quality factor ≤ 44 or Stratus signal strength < 5.
- Retinal Disease
- Presence of glaucoma
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
Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device
Time frame: 30 Minutes
The precision and agreement measures the thickness of RNFL and Full Retinal Thickness of the study device and is compared to the predicate device to show agreement. Keywords, ILM - Internal Limiting Membrane RPE - Retinal Pigment Epithelium RNFL - Retinal Nerve Fiber Layer
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Screening for Research Participants
Eye Diseases
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Disease and Glaucoma, run by Topcon Medical Systems, Inc. at 4 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 10 inclusion and 6 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 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Yes. Results are posted in the registry (first posted 17 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device (time frame: 30 Minutes). 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 28 Jun 2022.