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Completed

NCT Number: NCT02376868

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Western University of Health Sciences

Pomona, California, 91716, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Normal Group

  • 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

Exclusion criteria

for Normal Group

  • 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

Inclusion criteria

for Glaucoma Group

  • 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:
  • 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."
  • Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:
  • Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage;
  • Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles; or
  • Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue

Exclusion criteria

for Glaucoma Group

  • 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, defined as fixation losses> 20% or false positives> 33%, or false negatives > 33% in the study eye
  • Presence of any ocular pathology except glaucoma in the study eye
  • History of leukemia, dementia or multiple sclerosis
  • Concomitant use of hydroxychloroquine and chloroquine

Inclusion criteria

for Retina Disease Group

  • 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 retinal disease
  • lOP<= 21 mmHg in the study eye
  • BCVA 20/400 or better in the study eye
  • 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

  • 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
  • Presence of glaucoma or any ocular pathology other than a Retinal pathology (e.g., cornea pathology) in the study eye
  • Narrow angle in the study eye
  • History of leukemia, dementia or multiple sclerosis
  • Concomitant use of hydroxychloroquine and chloroquine

Treatment and study plan

3D OCT-1 Maestro

Device

OCT machines used for diagnostic purposes

iVue

Device

OCT machines used for diagnostic purposes

Primary outcomes

  1. Optic Disc Measurements (Optic Disc/Cup Size)

    Time frame: 1 Hour

    Reporting of the Optic Disc Size and Cup Size

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

    Time frame: 1 Hour

    RNFL thickness measured at different clock hours

  3. Full Retinal Thickness Measurements

    Time frame: 1 Hour

    Full Retinal Thicknesses measured in different quadrants of the scan

  4. Ganglion Cell Thickness Measurements

    Time frame: 1 Hour

    Ganglion Cell Thickness measured in different quadrants of the scan

Sponsors and collaborators

Lead sponsor

Topcon Medical Systems, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 3, 2015
Registry last updated
Jun 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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