Triton Fundus Autofluorescence and Fluorescein Angiography

Topcon DRI OCT Triton (Plus) Fundus Autofluorescence and Fluorescein Angiography Image Quality Evaluation Study

Compare the image quality of the fundus autofluorescence and fluorescein angiography

Study Overview

• Status: Completed
• Conditions: Medical Need for Fluorescein Angiography Imaging
• Intervention / Treatment: Device: Topcon DRI OCT Triton (plus); Device: TRC-50DX retinal camera

Detailed Description

The objectives of this study are to:

1. Compare the image quality of the fundus autofluorescence (FAF) photographs between DRI OCT Triton (plus) and TRC-50DX retinal camera.
2. Compare the image quality of the fluorescein angiography (FA) photographs between DRI OCT Triton (plus) and TRC-50DX retinal camera.

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10022
      • Vitreous Retina Macula Consultants of New York

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with medical need for FA imaging

Description

Inclusion Criteria

1. Subjects must be at least 18 years of age
2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3. Subjects who consent to, via clinic's standard FA consent form, and will undergo dye injection for FA imaging at the clinic visit based on medical need

Exclusion Criteria

1. Subjects unable to tolerate ophthalmic imaging
2. Subjects with ocular media not sufficiently clear to obtain acceptable fundus images
3. Patients with ocular motility dysfunction

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Medical need for FA imaging; Subjects deemed to have a medical need for FA imaging will be imaged on the Topcon DRI OCT Triton (plus) and TRC-50DX retinal camera	Device: Topcon DRI OCT Triton (plus); The Topcon DRI OCT Triton (plus) is an OCT with a fundus camera used for diagnostic purposes; Device: TRC-50DX retinal camera; The TRC-50DX retinal camera is a fundus camera used for diagnostic purposes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fundus autofluorescence image quality	Comparison of DRI OCT Triton (plus) and TRC-50DX photographs	1 Minute
Fluorescein angiography image quality at 120 seconds to 300 seconds after dye injection	Comparison of DRI OCT Triton (plus) and TRC-50DX photographs	120 seconds to 300 seconds
Fluorescein angiography image quality at greater than 300 seconds after dye injection	Comparison of DRI OCT Triton (plus) and TRC-50DX photographs	greater than 300 seconds

Collaborators and Investigators

• Sponsor: Topcon Medical Systems, Inc.
• Investigators: Study Chair: Charles Riesman, MS, Topcon Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2017
• Primary Completion (Actual): August 30, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: April 4, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

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

More Information

Terms related to this study

• Other Study ID Numbers: Triton FA FAF

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