Status:
COMPLETED
Clinical Study of the Optic Disc Parameters
Lead Sponsor:
Topcon Medical Systems, Inc.
Conditions:
Normal Healthy Subjects With No Known Ocular Diseases
Glaucomatous Eyes
Eligibility:
All Genders
18+ years
Phase:
NA
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
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT02277119
Start Date
October 1 2014
End Date
February 1 2015
Last Update
June 28 2022
Active Locations (2)
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1
Western University of Health Sciences
Pomona, California, United States, 91716
2
SUNY College of Optometry
New York, New York, United States, 10036