NCT02277119

Brief Summary

Assess the repeatability and agreement of the Optic Disc Parameters, Retinal Nerve Fiber Layer (RNFL) Thickness, and Full Retinal Thickness between the Maestro and iVue OCT devices

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

October 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 28, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

November 2, 2016

Completed
Last Updated

June 28, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

October 21, 2014

Results QC Date

May 31, 2016

Last Update Submit

June 3, 2022

Conditions

Normal Healthy Subjects With No Known Ocular DiseasesGlaucomatous EyesEyes With Retinal Diseases

Outcome Measures

Primary Outcomes (4)

  • Optic Disc Measurements (Optic Disc Size)

    Reporting of the Optic Disc Size difference between the Maestro and iVue

    1 Hour

  • Retinal Nerve Fiber Layer (RNFL) Thickness Measurements

    RNFL thickness measured

    1 Hour

  • Full Retinal Thickness Measurement

    Full Retinal Thicknesses Measurement

    1 Hour

  • Optic Disc Measurement (Cup Size)

    Reporting of the Cup size difference between the Maestro and iVue

    1 Hour

Study Arms (3)

Normal Eyes

EXPERIMENTAL

Subjects with no known ocular diseases will be scanned with the iVue and Maestro device

Device: MaestroDevice: iVue

Glaucomatous Eyes

EXPERIMENTAL

Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device

Device: MaestroDevice: iVue

Eyes with Retinal Diseases

EXPERIMENTAL

Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device

Device: MaestroDevice: iVue

Interventions

MaestroDEVICE

OCT machines used for diagnostic purposes

Eyes with Retinal DiseasesGlaucomatous EyesNormal Eyes
iVueDEVICE

OCT machines used for diagnostic purposes

Eyes with Retinal DiseasesGlaucomatous EyesNormal Eyes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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 (eyes without pathology)
  • lOPs 21mmHg bilaterally
  • BCVA 20/40 or better (each eye)
  • Both eyes must be free of eye disease

You may not qualify if:

  • Subjects that have participated in any previous study using 3D OCT-1 Maestro device.
  • Subjects unable to tolerate ophthalmic imaging
  • Subject with ocular media not sufficiently clear to obtain acceptable OCT images
  • HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD \< 5%
  • HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses\> 33% or false positives \> 25%, or false negatives \> 25%
  • Presence of any ocular pathology except for cataract
  • Previous ocular surgery or laser treatment, other than uncomplicated refractive procedure or cataract surgery, performed within six months prior to study scanning
  • 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
  • Subjects presenting at the site with glaucoma
  • BCVA 20/40 or better in the study eye
  • HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD \< 5% in the study eye
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Western University of Health Sciences

Pomona, California, 91716, United States

Location

SUNY College of Optometry

New York, New York, 10036, United States

Location

Results Point of Contact

Title
Charles Reisman
Organization
Topcon
CREISMAN@topcon.com
201-599-5283

Study Officials

  • Mike Sinai, PhD

    Topcon Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2014

First Posted

October 28, 2014

Study Start

October 1, 2014

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

June 28, 2022

Results First Posted

November 2, 2016

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)