Clinical Study of the Optic Disc Parameters

Study Overview
=================
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

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

Conditions
-----------------
Normal Healthy Subjects With No Known Ocular Diseases, Glaucomatous Eyes, Eyes With Retinal Diseases

Intervention / Treatment
-----------------
* Device: Maestro
* Device: iVue


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal Eyes<br>Subjects with no known ocular diseases will be scanned with the iVue and Maestro device | Device: Maestro<br>* OCT machines used for diagnostic purposes<br>Device: iVue<br>* OCT machines used for diagnostic purposes<br>|
| Experimental: Glaucomatous Eyes<br>Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device | Device: Maestro<br>* OCT machines used for diagnostic purposes<br>Device: iVue<br>* OCT machines used for diagnostic purposes<br>|
| Experimental: Eyes with Retinal Diseases<br>Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device | Device: Maestro<br>* OCT machines used for diagnostic purposes<br>Device: iVue<br>* OCT machines used for diagnostic purposes<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optic Disc Measurements (Optic Disc Size) | Reporting of the Optic Disc Size difference between the Maestro and iVue | 1 Hour | 
| Retinal Nerve Fiber Layer (RNFL) Thickness Measurements | RNFL thickness measured | 1 Hour | 
| Full Retinal Thickness Measurement | Full Retinal Thicknesses Measurement | 1 Hour | 
| Optic Disc Measurement (Cup Size) | Reporting of the Cup size difference between the Maestro and iVue | 1 Hour |