Maestro Agreement and Precision Study II

Topcon 3D OCT-1 Maestro Agreement and Precision Study II

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.

Study Overview

• Status: Completed
• Conditions: Normal Healthy Subjects With No Known Ocular Diseases; Glaucomatous Eyes; Eyes With Retinal Diseases
• Intervention / Treatment: Device: 3D OCT-1 Maestro; Device: iVue

• Study Type: Observational
• Enrollment (Actual): 101

Contacts and Locations

Study Locations

• United States
  • California
    • Pomona, California, United States, 91716
      • Western University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

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. lOP <=21 mmHg 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 previously enrolled in either the Maestro AP study or the Maestro2 study
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 (based on manufacturer's recommendation), defined as fixation losses> 20% or false positives> 33%, or false negatives> 33%

5. Visual field defects consistent with glaucomatous optic nerve damage with at least one of the following two findings:

   1. 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;
   2. Glaucoma hemi-field test "outside normal limits."
6. Presence of any ocular pathology except for cataract
7. Narrow angle
8. History of leukemia, dementia or multiple sclerosis
9. 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. BCVA 20/40 or better in the study eye

4. Visual field defects consistent with glaucomatous optic nerve damage based on with at least one of the following two findings:

   1. 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;
   2. Glaucoma hemi-field test "outside normal limits."

5. Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:

   1. Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage;
   2. Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles; or
   3. Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue

Exclusion Criteria for Glaucoma Group

1. Subjects previously enrolled in either the Maestro AP study or the Maestro2 study
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> 20% or false positives> 33%, or false negatives > 33% in the study eye
5. Presence of any ocular pathology except glaucoma in the study eye
6. History of leukemia, dementia or multiple sclerosis
7. Concomitant use of hydroxychloroquine and chloroquine

Inclusion Criteria for Retina Disease 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<= 21 mmHg 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 Disease Group

1. Subjects previously enrolled in either the Maestro AP study or the Maestro2 study
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. Narrow angle in the study eye
6. History of leukemia, dementia or multiple sclerosis
7. Concomitant use of hydroxychloroquine and chloroquine

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal Eyes; Subjects with no known ocular diseases will be scanned with the iVue and Maestro device	Device: 3D OCT-1 Maestro; OCT machines used for diagnostic purposes; Device: iVue; OCT machines used for diagnostic purposes
Glaucomatous Eyes; Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device	Device: 3D OCT-1 Maestro; OCT machines used for diagnostic purposes; Device: iVue; OCT machines used for diagnostic purposes
Eyes with Retinal Diseases; Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device	Device: 3D OCT-1 Maestro; OCT machines used for diagnostic purposes; Device: iVue; 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/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

Collaborators and Investigators

• Sponsor: Topcon Medical Systems, Inc.
• Investigators: Study Director: Charles Reisman, MS, Topcon Corporation

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: February 25, 2015
• First Submitted That Met QC Criteria: March 2, 2015
• First Posted (Estimate): March 3, 2015

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 6, 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: MaestroAPII