- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03080714
Triton Agreement and Precision Study
Topcon DRI OCT Triton Agreement and Precision Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Minnesota
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Willmar, Minnesota, United States, 56201
- Fischer Laser Eye Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria for Normal Group
- 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
Exclusion Criteria for Normal Group
- 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."
- Narrow angle
- History of leukemia, dementia or multiple sclerosis
- Concomitant use of hydroxychloroquine and chloroquine
Inclusion Criteria for Glaucoma Group
- 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
- 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
Exclusion Criteria for Glaucoma Group
- 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
Inclusion Criteria for Retina Disease Group
- 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
Exclusion Criteria for Retinal Disease Group
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
The Topcon DRI OCT Triton (plus) is an OCT machine used for diagnostic purposes
The 3D OCT-1 Maestro is an OCT machine used for diagnostic purposes
|
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
|
The Topcon DRI OCT Triton (plus) is an OCT machine used for diagnostic purposes
The 3D OCT-1 Maestro is an OCT machine used for diagnostic purposes
|
Subjects presenting with Glaucoma
Subjects with Glaucoma will be scanned on the Topcon DRI OCT Triton (plus) device and 3D OCT-1 Maestro
|
The Topcon DRI OCT Triton (plus) is an OCT machine used for diagnostic purposes
The 3D OCT-1 Maestro is an OCT machine used for diagnostic purposes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Retinal Thickness
Time Frame: 1 Minute
|
The thickness of the macula layer
|
1 Minute
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Charles Riesman, MS, Topcon Corporation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Triton AP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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