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OpenTrials
Completed

NCT Number: NCT02277119

Clinical Study of the Optic Disc Parameters

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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

Exclusion criteria

for Normal Group

  • 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

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
  • 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

Exclusion criteria

for Glaucoma Group

  • 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 unreliable, defined as fixation losses > 33% or false positives > 25%, or false negatives > 25% in the study eye
  • Presence of any ocular pathology except glaucoma in the study eye
  • 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
  • History of leukemia, dementia or multiple sclerosis
  • Concomitant use of hydroxychloroquine and chloroquine

Inclusion criteria

for Retinal 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 <= 21mmHg 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 Group

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

Treatment and study plan

Maestro

Device

OCT machines used for diagnostic purposes

iVue

Device

OCT machines used for diagnostic purposes

Primary outcomes

  1. Optic Disc Measurements (Optic Disc Size)

    Time frame: 1 Hour

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

  2. Retinal Nerve Fiber Layer (RNFL) Thickness Measurements

    Time frame: 1 Hour

    RNFL thickness measured

  3. Full Retinal Thickness Measurement

    Time frame: 1 Hour

    Full Retinal Thicknesses Measurement

  4. Optic Disc Measurement (Cup Size)

    Time frame: 1 Hour

    Reporting of the Cup size difference between the Maestro and iVue

Sponsors and collaborators

Lead sponsor

Topcon Medical Systems, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 28, 2014
Registry last updated
Jun 28, 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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