Fluorescein Angiography Imaging
Conditions
Brief summary
Comparisons for vascular structure visualization in the retina and choroid.
Interventions
DEVICEDRI 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
DEVICECirrus HD-OCT 5000
The Zeiss Cirrus HD-OCT 5000 is an OCT used for diagnostic purposes
DEVICETRC-50DX
The TRC-50DX retinal camera images the fundus used for diagnostic purposes
Sponsors
Topcon Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive percent agreement (PPA) for each OCT-A device using TRC-50DX as the reference | Day 1 | Comparison of OCT devices to TRC-50DX |
| Negative percent agreement (NPA) for each OCT-A device using TRC-50DX as the reference | Day 1 | Comparison of OCT devices to TRC-50DX |
| Agreement of pathology identification between the two OCT-A devices | Day 1 | Compare the pathology identifications between the OCT-A devices |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OCT-A image quality score (poor, average and good) | Day 1 | Image quality score |
Countries
United States
Outcome results
None listed