Clinical trial NCT02277119: Clinical Study of the Optic Disc Parameters
Official title: Topcon 3D OCT-1 Maestro Optic Disc and RNFL Study: Agreement and Repeatability Comparison With the iVue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normal Healthy Subjects With No Known Ocular Diseases
Glaucomatous Eyes
Eyes With Retinal Diseases
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2014-10-28
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


Eligibility 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

Primary outcomes:
measure: Optic Disc Measurements (Optic Disc Size)
timeFrame: 1 Hour
measure: Retinal Nerve Fiber Layer (RNFL) Thickness Measurements
timeFrame: 1 Hour
measure: Full Retinal Thickness Measurement
timeFrame: 1 Hour
measure: Optic Disc Measurement (Cup Size)
timeFrame: 1 Hour
Secondary outcomes:
Other outcomes:
Locations:
city: Pomona
country: United States
facility: Western University of Health Sciences
state: California
city: New York
country: United States
facility: SUNY College of Optometry
state: New York
Study officials:
affiliation: Topcon Corporation
name: Mike Sinai, PhD
role: STUDY_DIRECTOR
References: