Triton Fundus Autofluorescence and Fluorescein Angiography

Medical Need for Fluorescein Angiography Imaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03107104
• Other study ID #: Triton FA FAF
• Status: Completed
• Start date: March 30, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: June 2022
• Source: Topcon Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Compare the image quality of the fundus autofluorescence and fluorescein angiography

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 30, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medical Need for Fluorescein Angiography Imaging

Intervention

Device:
• Topcon DRI OCT Triton (plus)
The Topcon DRI OCT Triton (plus) is an OCT with a fundus camera used for diagnostic purposes
• TRC-50DX retinal camera
The TRC-50DX retinal camera is a fundus camera used for diagnostic purposes

Locations

Country	Name	City	State
United States	Vitreous Retina Macula Consultants of New York	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Topcon Medical Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fundus autofluorescence image quality	Comparison of DRI OCT Triton (plus) and TRC-50DX photographs	1 Minute
Primary	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
Primary	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