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

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03969303
• Other study ID #: C2018.008
• Status: Completed
• Start date: October 20, 2018
• Est. completion date: October 4, 2019

Study information

• Verified date: October 2020
• Source: Notal Vision Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: October 4, 2019
• Est. primary completion date: July 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• AMD - Age-Related Macular Degeneration
• Diabetic Macular Edema
• Macular Degeneration
• Macular Edema

Intervention

Device:
• Notal Vision Optical Coherence Tomography Device Version 2.5 (NOTAL-OCT V2.5)
OCT SCAN

Locations

Country	Name	City	State
United States	Elman Retina Group, PA	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Notal Vision Ltd.	Elman Retina Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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