NCT02376868

Brief Summary

Assess the repeatability and agreement of the Optic Disc Parameters, Retinal Nerve Fiber Layer (RNFL) Thickness, Full Retinal Thickness, and Ganglion Cell 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
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2015

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

February 25, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

4 months

First QC Date

February 25, 2015

Last Update Submit

June 6, 2022

Conditions

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

Outcome Measures

Primary Outcomes (4)

  • Optic Disc Measurements (Optic Disc/Cup Size)

    Reporting of the Optic Disc Size and Cup Size

    1 Hour

  • Retinal Nerve Fiber Layer (RNFL) Thickness Measurements At Different Clock Hours

    RNFL thickness measured at different clock hours

    1 Hour

  • Full Retinal Thickness Measurements

    Full Retinal Thicknesses measured in different quadrants of the scan

    1 Hour

  • Ganglion Cell Thickness Measurements

    Ganglion Cell Thickness measured in different quadrants of the scan

    1 Hour

Study Arms (3)

Normal Eyes

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

Device: 3D OCT-1 MaestroDevice: iVue

Glaucomatous Eyes

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

Device: 3D OCT-1 MaestroDevice: iVue

Eyes with Retinal Diseases

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

Device: 3D OCT-1 MaestroDevice: iVue

Interventions

3D OCT-1 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+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with no eye disease and subjects with retinal disease or glaucoma.

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)
  • lOP \<=21 mmHg bilaterally
  • BCVA 20/40 or better (each eye)
  • Both eyes must be free of eye disease

You may not qualify if:

  • Subjects previously enrolled in either the Maestro AP study or the Maestro2 study
  • 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 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 with 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."
  • Presence of any ocular pathology except for cataract
  • 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 with at least one of the following two findings:
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western University of Health Sciences

Pomona, California, 91716, United States

Location

Study Officials

  • Charles Reisman, MS

    Topcon Corporation

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 25, 2015

First Posted

March 3, 2015

Study Start

May 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

June 8, 2022

Record last verified: 2022-06

Locations

US(1)