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

Launched by TOPCON CORPORATION · Dec 13, 2019

Keywords

ClinConnect Summary

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Gender

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Eligibility 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 Officials