NCT03107104

Brief Summary

Compare the image quality of the fundus autofluorescence and fluorescein angiography

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

March 30, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

March 30, 2017

Last Update Submit

June 6, 2022

Conditions

Medical Need for Fluorescein Angiography Imaging

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

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)Device: TRC-50DX retinal camera

Interventions

Topcon DRI OCT Triton (plus)DEVICE

The Topcon DRI OCT Triton (plus) is an OCT with a fundus camera used for diagnostic purposes

Medical need for FA imaging
TRC-50DX retinal cameraDEVICE

The TRC-50DX retinal camera is a fundus camera used for diagnostic purposes

Medical need for FA imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with medical need for FA imaging

You may qualify if:

  • Subjects must be at least 18 years of age
  • Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
  • 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

You may not qualify if:

  • Subjects unable to tolerate ophthalmic imaging
  • Subjects with ocular media not sufficiently clear to obtain acceptable fundus images
  • Patients with ocular motility dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vitreous Retina Macula Consultants of New York

New York, New York, 10022, United States

Location

Study Officials

  • Charles Riesman, MS

    Topcon Corporation

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 11, 2017

Study Start

March 30, 2017

Primary Completion

August 30, 2017

Study Completion

September 30, 2017

Last Updated

June 8, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)