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

Notal Vision

Status: Completed

Conditions: AMD - Age-Related Macular Degeneration; Diabetic Macular Edema

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03969303

C2018.008

Details and patient eligibility

About

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.

Full 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

Enrollment: 287 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

287 participants in 1 patient group

NOTAL OCT v.2.5 and Commercial OCT on AMD Patients

Description:

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).

Treatment:

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