- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01809704
Clinical Validation of New OCT System
June 8, 2022 updated by: Topcon Medical Systems, Inc.
Topcon DRI OCT-1 Optical Coherence Tomography System for the Acquisition of Retinal Thickness Measurements and Ocular Images of the Posterior Chamber: Agreement and Precision Study
To demonstrate clinical substantial equivalence of DRI OCT-1 as comparable to the commercially available Cirrus
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
87
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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La Jolla, California, United States, 92093
- Hamilton Glaucoma Center
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New York
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Jamaica, New York, United States, 11425
- Murray Fingeret
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New York, New York, United States, 10022
- Vitreous Retina Macula Consultants of New York
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects that are Normal, or shows signs of Glaucoma or Retinal Ocular Pathology.
Description
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)
- IOP ≤ 21 mmHg bilaterally
- BCVA 20/40 or better bilaterally
- Both eyes must be free of eye disease
Exclusion Criteria for Normal Group
- 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 < 1%
- 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 < 1% in the study eye
Exclusion Criteria for Glaucoma Group
- 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 procedures 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 Retina Disease 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
- IOP <= 21 mmHg 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 Disease Group
- 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 procedures 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Normal
Normal results from clinical exam and free of ocular pathology.
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Glaucoma
Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma.
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Retina
Clinical exam results consistent with retina pathology
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Retinal Thickness
Time Frame: Day 1
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Day 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 25, 2013
Primary Completion (Actual)
July 3, 2013
Study Completion (Actual)
July 3, 2013
Study Registration Dates
First Submitted
March 8, 2013
First Submitted That Met QC Criteria
March 8, 2013
First Posted (Estimate)
March 13, 2013
Study Record Updates
Last Update Posted (Actual)
June 10, 2022
Last Update Submitted That Met QC Criteria
June 8, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- DC-03267
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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