Maestro Agreement and Precision Study II



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:May 2015
End Date:September 2015

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Topcon 3D OCT-1 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.


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
We found this trial at
1
site
Pomona, California 91766
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Pomona, CA
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