Topcon DRI OCT Triton With SS-OCT Angio Software Evaluation Study

Study Overview
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Brief Summary
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Comparisons for vascular structure visualization in the retina and choroid.

Official Title
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Topcon DRI OCT Triton With SS-OCT Angio Software Evaluation Study

Conditions
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Fluorescein Angiography Imaging

Intervention / Treatment
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* Device: DRI OCT Triton with SS-OCT Angio software
* Device: Cirrus HD-OCT 5000
* Device: TRC-50DX


Participation Criteria
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Eligibility Criteria
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NORMAL GROUP Inclusion Criteria Subjects 22 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 who have not participated in the DRI OCT Triton with SS OCT Angio software Evaluation Prestudy Subjects with normal eye exam bilaterally (laser refractive surgery and cataracts are acceptable) IOP ≤ 21 mmHg bilaterally BCVA 20/40 or better bilaterally Exclusion Criteria Subjects unable to tolerate ophthalmic imaging Subjects with ocular media not sufficiently clear to obtain acceptable OCT-A scans Subjects with known allergy to fluorescein, or subjects having liver disease, or end-stage renal disease Narrow angle History of leukemia, dementia or multiple sclerosis Concomitant use of hydroxychloroquine or chloroquine Subjects where the study eye was treated after screening and before imaging RETINAL GROUP Inclusion Criteria Subjects 22 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 who have not participated in the DRI OCT Triton with SS OCT Angio software Evaluation Prestudy BCVA 20/400 or better in the study eye 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 Subjects unable to tolerate ophthalmic imaging Subjects with ocular media not sufficiently clear to obtain acceptable OCT-A scans 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 History of leukemia, dementia or multiple sclerosis Concomitant use of hydroxychloroquine or chloroquine Subjects where the study eye was treated after screening and before imaging

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects Presenting with Normal Eyes<br>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 | Device: DRI OCT Triton with SS-OCT Angio software<br>* The Topcon DRI OCT Triton with SS-OCT Angio software is an OCT with a fundus camera used for diagnostic purposes<br>Device: Cirrus HD-OCT 5000<br>* The Zeiss Cirrus HD-OCT 5000 is an OCT used for diagnostic purposes<br>Device: TRC-50DX<br>* The TRC-50DX retinal camera images the fundus used for diagnostic purposes<br>|
| Subjects with retinal pathology present in the vasculature<br>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 | Device: DRI OCT Triton with SS-OCT Angio software<br>* The Topcon DRI OCT Triton with SS-OCT Angio software is an OCT with a fundus camera used for diagnostic purposes<br>Device: Cirrus HD-OCT 5000<br>* The Zeiss Cirrus HD-OCT 5000 is an OCT used for diagnostic purposes<br>Device: TRC-50DX<br>* The TRC-50DX retinal camera images the fundus used for diagnostic purposes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive percent agreement (PPA) for each OCT-A device using TRC-50DX as the reference | Comparison of OCT devices to TRC-50DX | Day 1 | 
| Negative percent agreement (NPA) for each OCT-A device using TRC-50DX as the reference | Comparison of OCT devices to TRC-50DX | Day 1 | 
| Agreement of pathology identification between the two OCT-A devices | Compare the pathology identifications between the OCT-A devices | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCT-A image quality score (poor, average and good) | Image quality score | Day 1 |