NCT03080714

Brief Summary

To Compare the agreement and precision between the Topcon DRI OCT Triton and the 3D OCT-1 Maestro with RDB.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 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 7, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

March 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

6 months

First QC Date

March 7, 2017

Last Update Submit

June 6, 2022

Conditions

Healthy EyesEye Diseases

Keywords

no known ocular pathologyGlaucomaRetinal Disease

Outcome Measures

Primary Outcomes (1)

  • Retinal Thickness

    The thickness of the macula layer

    1 Minute

Study Arms (3)

Subjects Presenting With Normal Eyes

Subjects with no known ocular diseases will be scanned on the Topcon DRI OCT Triton (plus) device and 3D OCT-1 Maestro

Device: Topcon DRI OCT Triton (plus)Device: 3D OCT-1 Maestro

Subjects presenting with Retinal Disease

Subjects with Retinal diseases will be scanned on the Topcon DRI OCT Triton (plus) device and 3D OCT-1 Maestro

Device: Topcon DRI OCT Triton (plus)Device: 3D OCT-1 Maestro

Subjects presenting with Glaucoma

Subjects with Glaucoma will be scanned on the Topcon DRI OCT Triton (plus) device and 3D OCT-1 Maestro

Device: Topcon DRI OCT Triton (plus)Device: 3D OCT-1 Maestro

Interventions

Topcon DRI OCT Triton (plus)DEVICE

The Topcon DRI OCT Triton (plus) is an OCT machine used for diagnostic purposes

Subjects Presenting With Normal EyesSubjects presenting with GlaucomaSubjects presenting with Retinal Disease
3D OCT-1 MaestroDEVICE

The 3D OCT-1 Maestro is an OCT machine used for diagnostic purposes

Subjects Presenting With Normal EyesSubjects presenting with GlaucomaSubjects presenting with Retinal Disease

Eligibility Criteria

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

Subjects presenting with Glaucoma, Retinal Diseases, or with no Ocular Pathology.

You may qualify if:

  • Subjects 18 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 presenting at the site with normal eyes bilaterally (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 images
  • HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses \> 20% or false positives \> 33%, or false negatives \> 33%
  • Visual field defects consistent with glaucomatous optic nerve damage based on at least one of the following two findings:
  • On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level;
  • Glaucoma hemi-field test "outside normal limits."
  • Narrow angle
  • History of leukemia, dementia or multiple sclerosis
  • Concomitant use of hydroxychloroquine and chloroquine
  • Subjects 18 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
  • BCVA 20/40 or better in the study eye
  • Visual field defects consistent with glaucomatous optic nerve damage based on at least one of the following two findings:
  • On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level;
  • Glaucoma hemi-field test "outside normal limits."
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fischer Laser Eye Center

Willmar, Minnesota, 56201, United States

Location

MeSH Terms

Conditions

Eye DiseasesGlaucomaRetinal Diseases

Condition Hierarchy (Ancestors)

Ocular Hypertension

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 7, 2017

First Posted

March 15, 2017

Study Start

March 13, 2017

Primary Completion

August 30, 2017

Study Completion

October 30, 2017

Last Updated

June 8, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)