Clinical Study of the Optic Disc Parameters

Topcon 3D OCT-1 Maestro Optic Disc and RNFL Study: Agreement and Repeatability Comparison With the iVue

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

Study Overview

• Status: Completed
• Conditions: Normal Healthy Subjects With No Known Ocular Diseases; Glaucomatous Eyes; Eyes With Retinal Diseases
• Intervention / Treatment: Device: iVue; Device: Maestro

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Pomona, California, United States, 91716
      • Western University of Health Sciences
  • New York
    • New York, New York, United States, 10036
      • SUNY College of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria for Normal Group

1. Subjects 18 years of age or older on the date of informed consent
2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3. Subjects presenting at the site with normal eyes (eyes without pathology)
4. lOPs 21mmHg bilaterally
5. BCVA 20/40 or better (each eye)
6. Both eyes must be free of eye disease

Exclusion Criteria for Normal Group

1. Subjects that have participated in any previous study using 3D OCT-1 Maestro device.
2. Subjects unable to tolerate ophthalmic imaging
3. Subject with ocular media not sufficiently clear to obtain acceptable OCT images
4. HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD < 5%
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%
6. Presence of any ocular pathology except for cataract
7. Previous ocular surgery or laser treatment, other than uncomplicated refractive procedure or cataract surgery, performed within six months prior to study scanning
8. Narrow angle
9. History of leukemia, dementia or multiple sclerosis
10. Concomitant use of hydroxychloroquine and chloroquine

Inclusion Criteria for Glaucoma Group

1. Subjects 18 years of age or older on the date of informed consent
2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3. Subjects presenting at the site with glaucoma
4. BCVA 20/40 or better in the study eye
5. 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

Exclusion Criteria for Glaucoma Group

1. Subjects that have participated in any previous study using 3D OCT-1 Maestro device.
2. Subjects unable to tolerate ophthalmic imaging
3. Subject with ocular media not sufficiently clear to obtain acceptable OCT images
4. HFA visual field (24-2 Sita Standard, white on white) result unreliable, defined as fixation losses > 33% or false positives > 25%, or false negatives > 25% in the study eye
5. Presence of any ocular pathology except glaucoma in the study eye
6. Previous ocular surgery or laser treatment, other than uncomplicated refractive procedure or cataract surgery, performed within six months prior to study scanning in the study eye
7. History of leukemia, dementia or multiple sclerosis
8. Concomitant use of hydroxychloroquine and chloroquine

Inclusion Criteria for Retinal Group

1. Subjects 18 years of age or older on the date of informed consent
2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3. Subjects presenting at the site with retinal disease
4. lOP <= 21mmHg in the study eye
5. BCVA 20/400 or better in the study eye
6. Diagnosis of some type of retinal pathology by investigator, may include, but not limited to: Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Cystoid Macula Edema, and others

Exclusion Criteria for Retinal Group

1. Subjects that have participated in any previous study using 3D OCT-1 Maestro device.
2. Subjects unable to tolerate ophthalmic imaging
3. Subject with ocular media not sufficiently clear to obtain acceptable OCT images
4. Presence of glaucoma or any ocular pathology other than a Retinal pathology (e.g., cornea pathology) in the study eye
5. Previous ocular surgery or laser treatment other than uncomplicated refractive procedure or cataract surgery performed within six months prior to study scanning in the study eye
6. Narrow angle in the study eye
7. History of leukemia, dementia or multiple sclerosis
8. Concomitant use of hydroxychloroquine and chloroquine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal Eyes; Subjects with no known ocular diseases will be scanned with the iVue and Maestro device	Device: iVue; OCT machines used for diagnostic purposes; Device: Maestro; OCT machines used for diagnostic purposes
Experimental: Glaucomatous Eyes; Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device	Device: iVue; OCT machines used for diagnostic purposes; Device: Maestro; OCT machines used for diagnostic purposes
Experimental: Eyes with Retinal Diseases; Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device	Device: iVue; OCT machines used for diagnostic purposes; Device: Maestro; OCT machines used for diagnostic purposes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Topcon Medical Systems, Inc.
• Investigators: Study Director: Mike Sinai, PhD, Topcon Corporation

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: October 21, 2014
• First Submitted That Met QC Criteria: October 24, 2014
• First Posted (Estimate): October 28, 2014

Study Record Updates

• Last Update Posted (Actual): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 3, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases
• Other Study ID Numbers: Maestro2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO