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

NCT04201340 | Completed FDA Device

• 1 other identifier: Triton OCT-A
• Study Type: observational
• Target: 211
• Locations: 1 country
• Sites: 1

Brief Summary

Comparisons for vascular structure visualization in the retina and choroid.

Conditions

Fluorescein Angiography Imaging

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• OCT-A image quality score (poor, average and good)

  Day 1

Study Arms (2)

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; Device: Cirrus HD-OCT 5000; Device: TRC-50DX

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; Device: Cirrus HD-OCT 5000; Device: TRC-50DX

Interventions

DRI OCT Triton with SS-OCT Angio software DEVICE

The Topcon DRI OCT Triton with SS-OCT Angio software is an OCT with a fundus camera used for diagnostic purposes

Subjects Presenting with Normal Eyes; Subjects with retinal pathology present in the vasculature

Cirrus HD-OCT 5000 DEVICE

The Zeiss Cirrus HD-OCT 5000 is an OCT used for diagnostic purposes

Subjects Presenting with Normal Eyes; Subjects with retinal pathology present in the vasculature

TRC-50DX DEVICE

The TRC-50DX retinal camera images the fundus used for diagnostic purposes

Subjects Presenting with Normal Eyes; Subjects with retinal pathology present in the vasculature

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with normal eyes or retinal pathology

You may qualify if:

• Subjects 22 years of age or older on the date of informed consent
• Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
• Subjects who have not participated in the DRI OCT Triton with SS OCT Angio software Evaluation Prestudy
• Subjects with normal eye exam bilaterally (laser refractive surgery and cataracts are acceptable)
• IOP ≤ 21 mmHg bilaterally
• BCVA 20/40 or better bilaterally

You may not qualify if:

• Subjects unable to tolerate ophthalmic imaging
• Subjects with ocular media not sufficiently clear to obtain acceptable OCT-A scans
• Subjects with known allergy to fluorescein, or subjects having liver disease, or end-stage renal disease
• Narrow angle
• History of leukemia, dementia or multiple sclerosis
• Concomitant use of hydroxychloroquine or chloroquine
• Subjects where the study eye was treated after screening and before imaging
• Subjects 22 years of age or older on the date of informed consent
• Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
• Subjects who have not participated in the DRI OCT Triton with SS OCT Angio software Evaluation Prestudy
• BCVA 20/400 or better in the study eye
• 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.
• Subjects unable to tolerate ophthalmic imaging
• Subjects with ocular media not sufficiently clear to obtain acceptable OCT-A scans
• 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

Sponsors & Collaborators

• Topcon Corporation: lead

Study Sites (1)

Southeast Retina Center

Augusta, Georgia, 30909, United States

Location

Study Officials

• Mayra Tafreshi

  Topcon Corporation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 17, 2019
• Study Start: December 11, 2019
• Primary Completion: July 28, 2022
• Study Completion: October 20, 2022
• Last Updated: December 8, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)