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Maestro Agreement and Precision Study II

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: NCT02376868
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : October 8, 2015
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, Full Retinal Thickness, and Ganglion Cell 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: 3D OCT-1 Maestro Device: iVue Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Topcon 3D OCT-1 Maestro Agreement and Precision Study II
Study Start Date : May 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Arm 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




Primary Outcome Measures :
  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



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. 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

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): NCT02376868


Locations
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United States, California
Western University of Health Sciences
Pomona, California, United States, 91716
Sponsors and Collaborators
Topcon Medical Systems, Inc.
Investigators
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Study Director: Charles Reisman, MS Topcon Corporation
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Responsible Party: Topcon Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT02376868    
Other Study ID Numbers: MaestroAPII
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Retinal Diseases
Eye Diseases