Healthy EyesNCT03080714
Triton Agreement and Precision Study
An observational study of Healthy Eyes and Eye Diseases, run by Topcon Medical Systems, Inc. at 1 site in United States.
Trial summary
To Compare the agreement and precision between the Topcon DRI OCT Triton and the 3D OCT-1 Maestro with RDB. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Eyes, Eye Diseases
- What is being tested?
- Topcon DRI OCT Triton (plus) and 3D OCT-1 Maestro
- Type of treatment
- Medical device
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2017to 30 Oct 2017
- 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: Subjects presenting with Glaucoma, Retinal Diseases, or with no Ocular Pathology.
Who may be able to join
- Subjects 18 years of age or older on the date of informed consent
- Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- Subjects presenting at the site with normal eyes bilaterally (cataracts are acceptable)
- IOP ≤ 21 mmHg bilaterally
- BCVA 20/40 or better bilaterally
- Subjects 18 years of age or older on the date of informed consent
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- Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- BCVA 20/40 or better in the study eye
- Visual field defects consistent with glaucomatous optic nerve damage based on at least one of the following two findings:
- On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level;
- Glaucoma hemi-field test "outside normal limits."
- Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:
- Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage;
- Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles; or
- Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue
- Subjects 18 years of age or older on the date of informed consent
- Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- Subjects presenting at the site with retinal disease
- IOP ≤ 21 mmHg in the study eye
- BCVA 20/400 or better in the study eye
- Diagnosis of some type of retinal pathology by investigator, may include, but not limited to: Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Cystoid Macula Edema, and others
Who cannot join
- Subjects unable to tolerate ophthalmic imaging
- Subjects with ocular media not sufficiently clear to obtain acceptable OCT images
- HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses > 20% or false positives > 33%, or false negatives > 33%
- Visual field defects consistent with glaucomatous optic nerve damage based on at least one of the following two findings:
- On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level;
- Glaucoma hemi-field test "outside normal limits."
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- Narrow angle
- History of leukemia, dementia or multiple sclerosis
- Concomitant use of hydroxychloroquine and chloroquine
- Subjects unable to tolerate ophthalmic imaging
- Subject with ocular media not sufficiently clear to obtain acceptable OCT images
- HFA visual field (24-2 Sita Standard, white on white) result unreliable, defined as fixation losses > 20% or false positives > 33%, or false negatives > 33% in the study eye
- Presence of any ocular pathology except glaucoma in the study eye (cataracts are acceptable)
- History of leukemia, dementia or multiple sclerosis
- Concomitant use of hydroxychloroquine and chloroquine
- Subjects unable to tolerate ophthalmic imaging
- Subject with ocular media not sufficiently clear to obtain acceptable OCT images
- Presence of glaucoma or any ocular pathology other than a Retinal pathology (e.g., cornea pathology) in the study eye (cataracts are acceptable)
- Narrow angle in the study eye
- History of leukemia, dementia or multiple sclerosis
- Concomitant use of hydroxychloroquine and chloroquine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topcon DRI OCT Triton Agreement and Precision Study
To Compare the agreement and precision between the Topcon DRI OCT Triton and the 3D OCT-1 Maestro with RDB.
Read the detailed description
The objectives of this study are to compare the agreement and precision between Topcon DRI OCT Triton and 3D OCT-1 Maestro with RDB by measuring the thickness layers.
- Conditions
- Healthy Eyes, Eye Diseases
- Being tested
- Topcon DRI OCT Triton (plus), 3D OCT-1 Maestro
- Keywords
- no known ocular pathology, Glaucoma, Retinal Disease
- Medical subject headings
- Eye Diseases, Glaucoma, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topcon DRI OCT Triton (plus)Device
The Topcon DRI OCT Triton (plus) is an OCT machine used for diagnostic purposes
3D OCT-1 MaestroDevice
The 3D OCT-1 Maestro is an OCT machine used for diagnostic purposes
| Study group | Role | What they receive |
|---|---|---|
| Subjects Presenting With Normal Eyes | Subjects with no known ocular diseases will be scanned on the Topcon DRI OCT Triton (plus) device and 3D OCT-1 Maestro Receives: Device: Topcon DRI OCT Triton (plus); Device: 3D OCT-1 Maestro | |
| Subjects presenting with Retinal Disease | Subjects with Retinal diseases will be scanned on the Topcon DRI OCT Triton (plus) device and 3D OCT-1 Maestro Receives: Device: Topcon DRI OCT Triton (plus); Device: 3D OCT-1 Maestro | |
| Subjects presenting with Glaucoma | Subjects with Glaucoma will be scanned on the Topcon DRI OCT Triton (plus) device and 3D OCT-1 Maestro Receives: Device: Topcon DRI OCT Triton (plus); Device: 3D OCT-1 Maestro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal Thickness
The thickness of the macula layer
Measured: 1 Minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start13 Mar 2017
- Primary completion30 Aug 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy EyesStudies 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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Topcon Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Riesman, MS, Study chair, Topcon Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080714
- Sponsor's protocol ID
- Triton AP
- Status last verified
- Jun 2022
- First submitted
- 7 Mar 2017
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topcon DRI OCT Triton Agreement and Precision Study
- ClinicalTrials.gov ID
- NCT03080714
- Acronym / sponsor ID
- Triton AP
- Conditions
- Healthy Eyes, Eye Diseases
- Keywords
- no known ocular pathology, Glaucoma, Retinal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Topcon Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 15 Mar 2017 (actual)
- 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 Compare the agreement and precision between the Topcon DRI OCT Triton and the 3D OCT-1 Maestro with RDB.
Detailed description
The objectives of this study are to compare the agreement and precision between Topcon DRI OCT Triton and 3D OCT-1 Maestro with RDB by measuring the thickness layers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjects Presenting With Normal Eyes | – | Device: Topcon DRI OCT Triton (plus), Device: 3D OCT-1 MaestroSubjects with no known ocular diseases will be scanned on the Topcon DRI OCT Triton (plus) device and 3D OCT-1 Maestro |
| Subjects presenting with Retinal Disease | – | Device: Topcon DRI OCT Triton (plus), Device: 3D OCT-1 MaestroSubjects with Retinal diseases will be scanned on the Topcon DRI OCT Triton (plus) device and 3D OCT-1 Maestro |
| Subjects presenting with Glaucoma | – | Device: Topcon DRI OCT Triton (plus), Device: 3D OCT-1 MaestroSubjects with Glaucoma will be scanned on the Topcon DRI OCT Triton (plus) device and 3D OCT-1 Maestro |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects presenting with Glaucoma, Retinal Diseases, or with no Ocular Pathology.
Key inclusion criteria (21 listed)
- Subjects 18 years of age or older on the date of informed consent
- Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- Subjects presenting at the site with normal eyes bilaterally (cataracts are acceptable)
- IOP ≤ 21 mmHg bilaterally
- BCVA 20/40 or better bilaterally
Key exclusion criteria (21 listed)
- Subjects unable to tolerate ophthalmic imaging
- Subjects with ocular media not sufficiently clear to obtain acceptable OCT images
- HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses > 20% or false positives > 33%, or false negatives > 33%
- Visual field defects consistent with glaucomatous optic nerve damage based on at least one of the following two findings:
- Narrow angle
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 |
|---|---|---|
| Topcon DRI OCT Triton (plus)The Topcon DRI OCT Triton (plus) is an OCT machine used for diagnostic purposes | Device | Subjects Presenting With Normal Eyes, Subjects presenting with Glaucoma, Subjects presenting with Retinal Disease |
| 3D OCT-1 MaestroThe 3D OCT-1 Maestro is an OCT machine used for diagnostic purposes | Device | Subjects Presenting With Normal Eyes, Subjects presenting with Glaucoma, Subjects presenting with Retinal Disease |
Primary outcome
Retinal Thickness
Time frame: 1 Minute
The thickness of the macula layer
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 8 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Charles Riesman, MS study chair
Topcon Corporation
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 Eyes and Eye Diseases, run by Topcon Medical Systems, Inc. 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 21 inclusion and 21 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 8 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 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: 1 Minute). 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 8 Jun 2022.