Study Results
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View full resultsBasic Information
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COMPLETED
NA
109 participants
INTERVENTIONAL
2014-10-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
SINGLE
Study Groups
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Normal Eyes
Subjects with no known ocular diseases will be scanned with the iVue and Maestro device
Maestro
OCT machines used for diagnostic purposes
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
Maestro
OCT machines used for diagnostic purposes
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
Maestro
OCT machines used for diagnostic purposes
iVue
OCT machines used for diagnostic purposes
Interventions
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Maestro
OCT machines used for diagnostic purposes
iVue
OCT machines used for diagnostic purposes
Eligibility Criteria
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Inclusion Criteria
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
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
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
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
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
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
18 Years
ALL
Yes
Sponsors
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Topcon Medical Systems, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mike Sinai, PhD
Role: STUDY_DIRECTOR
Topcon Corporation
Locations
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Western University of Health Sciences
Pomona, California, United States
SUNY College of Optometry
New York, New York, United States
Countries
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Other Identifiers
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Maestro2
Identifier Type: -
Identifier Source: org_study_id
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