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NOTAL-OCT V.2.5 vs Commercial OCT in AMD Patients

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ClinicalTrials.gov Identifier: NCT03969303
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : July 1, 2019
Sponsor:
Collaborator:
Elman Retina Group
Information provided by (Responsible Party):
Notal Vision Ltd

Brief Summary:

Primary objective:

To evaluate the level of agreement between the NOTAL-OCT V2.5 and a commercial OCT in the presence of fluid as identified in the OCT images, in the central 10 degrees of the macula in AMD (Age-related Macular Degeneration) patients.

Secondary objectives:

  1. To evaluate the level of agreement between the NOTAL-OCT V2.5 and a commercial OCT in the presence of fluid as identified in the OCT images, in the central 10 degrees of the macula in DME (Diabetic Macular Edema) patients.
  2. To evaluate patient experience when self-operating the Notal-OCT V2.5.

Condition or disease Intervention/treatment
AMD - Age-Related Macular Degeneration Diabetic Macular Edema Device: Notal Vision Optical Coherence Tomography Device Version 2.5 (NOTAL-OCT V2.5)

Detailed Description:

To evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of AMD patients. OCT images from the central 10 degrees of the macula in AMD patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images.

To evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of DME patients. OCT images from the central 10 degrees of the macula in DME patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images.

Patients will complete a questionnaire regarding the usability of the NOTAL-OCT v.2.5 device


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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison Between Retinal Images Captured by NOTAL-OCT V2.5 and Zeiss Cirrus / Heidelberg Spectralis SD OCT - Study Protocol
Actual Study Start Date : October 20, 2018
Estimated Primary Completion Date : October 20, 2019
Estimated Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
NOTAL OCT v.2.5 and Commercial OCT on AMD Patients
OCT Images will be obtained in the central 10 degrees of the macula in AMD patients using the NOTAL OCT v.2.5 device and a Commercial device (Zeiss Cirrus/Heidelberg SPECTRALIS).
Device: Notal Vision Optical Coherence Tomography Device Version 2.5 (NOTAL-OCT V2.5)
OCT SCAN




Primary Outcome Measures :
  1. Comparison of presence/absence of fluid on OCT images from NOTAL-OCT v.2.5 device with a commercial OCT device, in AMD (Age-related Macular Degeneration) patients [ Time Frame: less than an hour ]
    To evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of AMD patients. OCT images from the central 10 degrees of the macula in AMD patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images.


Secondary Outcome Measures :
  1. Comparison of presence/absence of fluid on OCT images from NOTAL-OCT v.2.5 device with a commercial OCT device, in DR (Diabetic Retinopathy) patients [ Time Frame: less then an hour ]
    To evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of DR patients. OCT images from the central 10 degrees of the macula in DR patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images.

  2. Patient experience using the NOTAL-OCT v.2.5 device [ Time Frame: less than an hour ]
    Patients will complete a questionnaire with 13 statements or questions regarding the usability of the NOTAL-OCT v.2.5 device. For the first 10 statements, patients are asked to specify a level of agreement to the statement. The scale is named "Level of Agreement" and ranges from 1 = strongly agree, to 5 = strongly disagree. A patient's indicating a value of 1 is considered to be a better outcome. The remaining 3 questions are free-form.



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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:   Probability Sample
Study Population
AMD and DME patients
Criteria

Inclusion Criteria:

  • Ability and willingness to give informed consent (IC)
  • 18 years of age or older
  • Diagnosis of AMD (age-related macular degeneration) and/or DME (diabetic macular edema) in the study eye as confirmed by the investigator and recorded in the patient's clinical record
  • Ability to undergo OCT (optical coherence tomography) testing
  • Visual acuity of 20/400 Snellen (6/120) or better in the study eye

Exclusion Criteria:

- Any ophthalmic or systemic condition that in the opinion of the investigator would preclude the patient from participating in the study.


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): NCT03969303


Contacts
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Contact: Muki Rapp +972 52 6118884 rapp@notalvision.com
Contact: Michael Elman elman@elmanretina.com

Locations
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United States, Maryland
Elman Retina Group, PA Recruiting
Baltimore, Maryland, United States, 21237
Contact: JoAnn Starr         
Principal Investigator: Michael Elman, MD         
Sponsors and Collaborators
Notal Vision Ltd
Elman Retina Group
Investigators
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Principal Investigator: Michael Elman Michael Elman, M.D. 9114 Philadelphia Rd #310 Baltimore, Maryland 21237

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Responsible Party: Notal Vision Ltd
ClinicalTrials.gov Identifier: NCT03969303     History of Changes
Other Study ID Numbers: C2018.008
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Macular Edema
Retinal Degeneration
Retinal Diseases
Eye Diseases