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Clinical Study of the Optic Disc Parameters

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02277119
Recruitment Status : Completed
First Posted : October 28, 2014
Results First Posted : November 2, 2016
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Topcon Medical Systems, Inc.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Normal Healthy Subjects With No Known Ocular Diseases Glaucomatous Eyes Eyes With Retinal Diseases Device: Maestro Device: iVue Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Topcon 3D OCT-1 Maestro Optic Disc and RNFL Study: Agreement and Repeatability Comparison With the iVue
Study Start Date : October 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : February 2015

Arm Intervention/treatment
Experimental: Normal Eyes
Subjects with no known ocular diseases will be scanned with the iVue and Maestro device
Device: Maestro
OCT machines used for diagnostic purposes

Device: iVue
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: Maestro
OCT machines used for diagnostic purposes

Device: iVue
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: Maestro
OCT machines used for diagnostic purposes

Device: iVue
OCT machines used for diagnostic purposes




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277119


Locations
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United States, California
Western University of Health Sciences
Pomona, California, United States, 91716
United States, New York
SUNY College of Optometry
New York, New York, United States, 10036
Sponsors and Collaborators
Topcon Medical Systems, Inc.
Investigators
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Study Director: Mike Sinai, PhD Topcon Corporation
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Responsible Party: Topcon Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT02277119    
Other Study ID Numbers: Maestro2
First Posted: October 28, 2014    Key Record Dates
Results First Posted: November 2, 2016
Last Update Posted: November 2, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Retinal Diseases
Eye Diseases