Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-24 @ 7:19 PM
NCT ID:
NCT03969303
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:
NCT03969303
Study Brief:
Protocol Section:
NCT03969303