NCT Number: NCT01809704
Clinical Validation of New OCT System
To demonstrate clinical substantial equivalence of DRI OCT-1 as comparable to the commercially available Cirrus
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Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Hamilton Glaucoma Center, La Jolla, California, United States
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Retinal Thickness
Time frame: Day 1
Sponsors and collaborators
Lead sponsor
Topcon Medical Systems, Inc.
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2013
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Mar 13, 2013
- Registry last updated
- Jun 10, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.