NCT03969303

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 287 (actual)
• Sponsor: Notal Vision Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

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

Interventions

Type	Name	Description
DEVICE	Notal Vision Optical Coherence Tomography Device Version 2.5 (NOTAL-OCT V2.5)	OCT SCAN

Timeline

• Start date: 2018-10-20
• Primary completion: 2019-07-11
• Completion: 2019-10-04
• First posted: 2019-05-31
• Last updated: 2020-11-12

Locations

1 site across 1 country: United States