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Macular Thickness Measurements Using Retinal-thickness 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. Read our disclaimer for details. Identifier: NCT03030729
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : June 17, 2019
Information provided by (Responsible Party):
Notal Vision Ltd

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

Condition or disease
Age-Related Macular Degeneration Diabetic Retinopathy

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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Macular Thickness Measurements Using RTOCT
Actual Study Start Date : March 14, 2017
Actual Primary Completion Date : January 14, 2018
Actual Study Completion Date : January 14, 2018

Resource links provided by the National Library of Medicine

Intermediate AMD
Advanced AMD
DR without macular edema
DR with macular edema

Primary Outcome Measures :
  1. Comparison between retinal measurements, done by the RTOCT device and a commercial OCT [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

Exclusion Criteria:

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

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 identifier (NCT number): NCT03030729

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Sorasky Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Notal Vision Ltd
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Responsible Party: Notal Vision Ltd Identifier: NCT03030729    
Other Study ID Numbers: TLV-0025-16
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: January 2017
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