Topcon DRI OCT Triton With SS-OCT Angio Software Evaluation Study
NCT ID: NCT04201340
Last Updated: 2022-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
211 participants
OBSERVATIONAL
2019-12-11
2022-10-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Subjects Presenting with Normal Eyes
Subjects with no known ocular diseases will be imaged on the DRI OCT Triton with SS-OCT Angio software, Zeiss Cirrus HD-OCT 5000, and TRC-50DX
DRI OCT Triton with SS-OCT Angio software
The Topcon DRI OCT Triton with SS-OCT Angio software is an OCT with a fundus camera used for diagnostic purposes
Cirrus HD-OCT 5000
The Zeiss Cirrus HD-OCT 5000 is an OCT used for diagnostic purposes
TRC-50DX
The TRC-50DX retinal camera images the fundus used for diagnostic purposes
Subjects with retinal pathology present in the vasculature
Subjects with retinal pathology likely to present in the vasculature will be imaged on the DRI OCT Triton with SS-OCT Angio software, Zeiss Cirrus HD-OCT 5000, and TRC-50DX
DRI OCT Triton with SS-OCT Angio software
The Topcon DRI OCT Triton with SS-OCT Angio software is an OCT with a fundus camera used for diagnostic purposes
Cirrus HD-OCT 5000
The Zeiss Cirrus HD-OCT 5000 is an OCT used for diagnostic purposes
TRC-50DX
The TRC-50DX retinal camera images the fundus used for diagnostic purposes
Interventions
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DRI OCT Triton with SS-OCT Angio software
The Topcon DRI OCT Triton with SS-OCT Angio software is an OCT with a fundus camera used for diagnostic purposes
Cirrus HD-OCT 5000
The Zeiss Cirrus HD-OCT 5000 is an OCT used for diagnostic purposes
TRC-50DX
The TRC-50DX retinal camera images the fundus used for diagnostic purposes
Eligibility Criteria
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Inclusion Criteria
2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3. Subjects who have not participated in the DRI OCT Triton with SS OCT Angio software Evaluation Prestudy
4. Subjects with normal eye exam bilaterally (laser refractive surgery and cataracts are acceptable)
5. IOP ≤ 21 mmHg bilaterally
6. BCVA 20/40 or better bilaterally
1. Subjects 22 years of age or older on the date of informed consent
2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3. Subjects who have not participated in the DRI OCT Triton with SS OCT Angio software Evaluation Prestudy
4. BCVA 20/400 or better in the study eye
5. Diagnosis of some type of retinal pathology likely to present in the vasculature in at least one eye as determined by the investigator, may include, but is not limited to: Diabetic retinopathy, Retinal Vein occlusions, Exudative AMD or Macular telangiectasia with expected presentation in the vasculature of, including but not limited to, microaneurysms, capillary dropout and/or choroidal neovascularization.
Exclusion Criteria
2. Subjects with ocular media not sufficiently clear to obtain acceptable OCT-A scans
3. Subjects with known allergy to fluorescein, or subjects having liver disease, or end-stage renal disease
4. Narrow angle
5. History of leukemia, dementia or multiple sclerosis
6. Concomitant use of hydroxychloroquine or chloroquine
7. Subjects where the study eye was treated after screening and before imaging
1. Subjects unable to tolerate ophthalmic imaging
2. Subjects with ocular media not sufficiently clear to obtain acceptable OCT-A scans
3. Subjects with known allergy to fluorescein or if ICGA is clinically indicated, indocyanine green dyes, shellfish, iodine, or subjects having liver disease, or end-stage renal disease
4. History of leukemia, dementia or multiple sclerosis
5. Concomitant use of hydroxychloroquine or chloroquine
6. Subjects where the study eye was treated after screening and before imaging
22 Years
ALL
Yes
Sponsors
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Topcon Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Mayra Tafreshi
Role: STUDY_DIRECTOR
Topcon Corporation
Locations
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Southeast Retina Center
Augusta, Georgia, United States
Countries
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Other Identifiers
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Triton OCT-A
Identifier Type: -
Identifier Source: org_study_id
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