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Retinal Imaging Using NOTAL-OCT

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03374020
Recruitment Status : Not yet recruiting
First Posted : December 14, 2017
Last Update Posted : December 14, 2017
Information provided by (Responsible Party):
Notal Vision Ltd

Brief Summary:
Comparison between retinal measurements, done by the Notal-OCT imaging and a commercial OCT (Optical Coherence Tomography)

Condition or disease Intervention/treatment
Age-Related Macular Degeneration Diabetic Retinopathy Device: Notal OCT

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Retinal Imaging Using NOTAL-OCT
Estimated Study Start Date : December 15, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Intermediate AMD Device: Notal OCT
Imaging using Notal OCT

Advanced AMD Device: Notal OCT
Imaging using Notal OCT

DR without macular edema Device: Notal OCT
Imaging using Notal OCT

DR with macular edema Device: Notal OCT
Imaging using Notal OCT

Primary Outcome Measures :
  1. The level of agreement between NOTAL-OCT and commercial OCT in detecting fluid in the 10 central degrees of the macula. [ Time Frame: 1 year ]
    OCT B-scans from both devices will be graded for fluid by an eye care professional and results per macula will be analyzed. A binary decision "there is fluid" or "there is no fluid" will be given to each macula (10 central degrees). Then agreement between decisions, commercial and Notal OCT, will be compared

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:   No
Sampling Method:   Non-Probability Sample
Study Population
  1. AMD population - intermediate and advanced AMD (with active and non-active CNV)
  2. DR population. Patient with and without DME

Inclusion Criteria:

  1. Ability and agreement to give informed consent (IC)
  2. Diagnosis of AMD or DR in SE by OCT
  3. Ability to undergo OCT scans
  4. VA of 20/160 or better in SE

Exclusion Criteria:

  1. AMD and DR in the same SE
  2. Evidence of macular disease other than AMD or DME in SE

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Responsible Party: Notal Vision Ltd Identifier: NCT03374020     History of Changes
Other Study ID Numbers: BNZ-0077-017
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Macular Degeneration
Diabetic Retinopathy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases