Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Validation of New OCT System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date March 8, 2013
First Posted Date March 13, 2013
Last Update Posted Date January 23, 2014
Study Start Date February 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 8, 2013)
Retinal Thickness [ Time Frame: Day 1 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Validation of New OCT System
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
Brief Summary To demonstrate clinical substantial equivalence of DRI OCT-1 as comparable to the commercially available Cirrus
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects that are Normal, or shows signs of Glaucoma or Retinal Ocular Pathology.
Condition Normal and Ocular Pathology.
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: March 8, 2013)
150
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01809704
Other Study ID Numbers DC-03267
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Topcon Medical Systems, Inc.
Study Sponsor Topcon Medical Systems, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Michael Sinai, PhD Director of Clinical Marketing
PRS Account Topcon Medical Systems, Inc.
Verification Date January 2014