Clinical trial NCT04201340: Topcon DRI OCT Triton With SS-OCT Angio Software Evaluation Study
Official title: Topcon DRI OCT Triton With SS-OCT Angio Software Evaluation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fluorescein Angiography Imaging
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2019-12-17
Enrollment: 211
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with normal eyes or retinal pathology

Brief summary: Comparisons for vascular structure visualization in the retina and choroid.


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

Primary outcomes:
measure: Positive percent agreement (PPA) for each OCT-A device using TRC-50DX as the reference
timeFrame: Day 1
measure: Negative percent agreement (NPA) for each OCT-A device using TRC-50DX as the reference
timeFrame: Day 1
measure: Agreement of pathology identification between the two OCT-A devices
timeFrame: Day 1
Secondary outcomes:
measure: OCT-A image quality score (poor, average and good)
timeFrame: Day 1
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
Study officials:
affiliation: Topcon Corporation
name: Mayra Tafreshi
role: STUDY_DIRECTOR
References: