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

Completed

• Conditions: AMD - Age-Related Macular Degeneration; Diabetic Macular Edema
• Interventions: Device: Notal Vision Optical Coherence Tomography Device Version 2.5 (NOTAL-OCT V2.5)

• Registration Number: NCT03969303
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-10-20
• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2019-05-27
• Study First Posted: 2019-05-31
• Primary Completion: 2019-07-11
• Study Completion: 2019-10-04
• Status Verified: 2020-10
• Last Update Submitted: 2020-11-10
• Last Update Posted: 2020-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NOTAL OCT v.2.5 and Commercial OCT on AMD Patients	Notal Vision Optical Coherence Tomography Device Version 2.5 (NOTAL-OCT V2.5)	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).

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
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	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.
Patient experience using the NOTAL-OCT v.2.5 device	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.

Trial Locations

Locations (1)

Elman Retina Group, PA; 🇺🇸 Baltimore, Maryland, United States