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

Comparison Between Retinal Images Captured by NOTAL-OCT V2.5 and Zeiss Cirrus / Heidelberg Spectralis SD OCT - Study Protocol

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema; AMD - Age-Related Macular Degeneration
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Actual): 287

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Elman Retina Group, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

AMD and DME patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	less than an hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	less then an hour
Patient experience using the NOTAL-OCT v.2.5 device	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.	less than an hour

Collaborators and Investigators

• Sponsor: Notal Vision Ltd.
• Collaborators: Elman Retina Group
• Investigators: Principal Investigator: Michael Elman, Michael Elman, M.D. 9114 Philadelphia Rd #310 Baltimore, Maryland 21237

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 20, 2018
• Primary Completion (ACTUAL): July 11, 2019
• Study Completion (ACTUAL): October 4, 2019

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: May 27, 2019
• First Posted (ACTUAL): May 31, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema
• Other Study ID Numbers: C2018.008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No