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Clinical Validation of New OCT System

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ClinicalTrials.gov Identifier: NCT01809704
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : January 23, 2014
Sponsor:
Information provided by (Responsible Party):
Topcon Medical Systems, Inc.

Brief Summary:
To demonstrate clinical substantial equivalence of DRI OCT-1 as comparable to the commercially available Cirrus

Condition or disease
Normal and Ocular Pathology.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Study Start Date : February 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : December 2013

Group/Cohort
Normal
Normal results from clinical exam and free of ocular pathology.
Glaucoma
Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma.
Retina
Clinical exam results consistent with retina pathology



Primary Outcome Measures :
  1. Retinal Thickness [ Time Frame: Day 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects that are Normal, or shows signs of Glaucoma or Retinal Ocular Pathology.
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. IOP ≤ 21 mmHg bilaterally
  5. BCVA 20/40 or better bilaterally
  6. Both eyes must be free of eye disease

Exclusion Criteria for Normal Group

  1. Subjects unable to tolerate ophthalmic imaging
  2. Subject with ocular media not sufficiently clear to obtain acceptable OCT images
  3. HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD < 1%
  4. 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%
  5. Presence of any ocular pathology except for cataract
  6. Previous ocular surgery or laser treatment other than uncomplicated refractive procedure or cataract surgery performed within six months prior to study scanning
  7. Narrow angle
  8. History of leukemia, dementia or multiple sclerosis
  9. 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 < 1% in the study eye

Exclusion Criteria for Glaucoma Group

  1. Subjects unable to tolerate ophthalmic imaging
  2. Subject with ocular media not sufficiently clear to obtain acceptable OCT images
  3. 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
  4. Presence of any ocular pathology except glaucoma in the study eye
  5. Previous ocular surgery or laser treatment other than uncomplicated procedures performed within six months prior to study scanning in the study eye
  6. History of leukemia, dementia or multiple sclerosis
  7. Concomitant use of hydroxychloroquine and chloroquine

Inclusion Criteria for Retina Disease 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. IOP <= 21 mmHg 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 Disease Group

  1. Subjects unable to tolerate ophthalmic imaging
  2. Subject with ocular media not sufficiently clear to obtain acceptable OCT images
  3. Presence of glaucoma or any ocular pathology other than a Retinal pathology (e.g., cornea pathology) in the study eye
  4. Previous ocular surgery or laser treatment other than uncomplicated procedures performed within six months prior to study scanning in the study eye
  5. Narrow angle in the study eye
  6. History of leukemia, dementia or multiple sclerosis
  7. Concomitant use of hydroxychloroquine and chloroquine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809704


Locations
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United States, California
Hamilton Glaucoma Center
La Jolla, California, United States, 92093
United States, New York
Murray Fingeret
Jamaica, New York, United States, 11425
Vitreous Retina Macula Consultants of New York
New York, New York, United States, 10022
Sponsors and Collaborators
Topcon Medical Systems, Inc.
Investigators
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Principal Investigator: Michael Sinai, PhD Director of Clinical Marketing

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Responsible Party: Topcon Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT01809704     History of Changes
Other Study ID Numbers: DC-03267
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: January 23, 2014
Last Verified: January 2014