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

Topcon

Status: Completed

Conditions: Fluorescein Angiography Imaging

Treatments: Device: Cirrus HD-OCT 5000; Device: TRC-50DX; Device: DRI OCT Triton with SS-OCT Angio software

Study type: Observational

Funder types: Industry

Identifiers

NCT04201340

Triton OCT-A

Details and patient eligibility

About

Comparisons for vascular structure visualization in the retina and choroid.

Enrollment: 211 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

NORMAL GROUP Inclusion Criteria

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. 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

Exclusion Criteria

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 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

RETINAL GROUP Inclusion Criteria

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

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

Trial design

211 participants in 2 patient groups

Subjects Presenting with Normal Eyes

Description:

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

Treatment:

Device: DRI OCT Triton with SS-OCT Angio software

Device: Cirrus HD-OCT 5000

Device: TRC-50DX

Subjects with retinal pathology present in the vasculature

Description:

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

Treatment:

Device: DRI OCT Triton with SS-OCT Angio software

Device: Cirrus HD-OCT 5000

Device: TRC-50DX