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

Comparisons for vascular structure visualization in the retina and choroid.

Study Overview

• Status: Completed
• Conditions: Fluorescein Angiography Imaging
• Intervention / Treatment: Device: DRI OCT Triton with SS-OCT Angio software; Device: Cirrus HD-OCT 5000; Device: TRC-50DX

• Study Type: Observational
• Enrollment (Actual): 211

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Southeast Retina Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with normal eyes or retinal pathology

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Topcon Corporation
• Investigators: Study Director: Mayra Tafreshi, Topcon Corporation

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2019
• Primary Completion (Actual): July 28, 2022
• Study Completion (Actual): October 20, 2022

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: December 13, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Triton OCT-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No