Status:
COMPLETED
Clinical Validation of New OCT System
Lead Sponsor:
Topcon Medical Systems, Inc.
Conditions:
Subjects Presenting With Normal or With Ocular Pathology
Eligibility:
All Genders
18+ years
Brief Summary
To demonstrate clinical substantial equivalence of DRI OCT-1 as comparable to the commercially available Cirrus
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)
- 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
Exclusion
Key Trial Info
Start Date :
February 25 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 3 2013
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT01809704
Start Date
February 25 2013
End Date
July 3 2013
Last Update
June 10 2022
Active Locations (3)
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1
Hamilton Glaucoma Center
La Jolla, California, United States, 92093
2
Murray Fingeret
Jamaica, New York, United States, 11425
3
Vitreous Retina Macula Consultants of New York
New York, New York, United States, 10022