Retinal Imaging Using NOTAL-OCT V2.5

Notal Vision

Status: Completed

Conditions: AMD

Treatments: Device: NOTAL OCT V2.5

Study type: Observational

Funder types: Industry

Identifiers

NCT03600519

BNZ-0060-18

Details and patient eligibility

About

Primary objectives:

To compare between retinal measurements, done by the NOTAL-OCT V2.5 device and a commercial OCT.

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.
2. To evaluate the repeatability of the NOTAL-OCT V2.5

Full description

Study population:

1. AMD population - intermediate and advanced AMD (with active and nonactive CNV)
2. DR population. Patient with and without DME

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Inclusion Criteria:

   a- Ability and agreement to give informed consent (IC) b -Diagnosis of AMD or DR in SE by OCT c- Ability to undergo OCT scans d- VA of 20/400 (6/120) or better in SE

2. Exclusion Criteria:

   1. AMD and DR in the same SE
   2. Evidence of macular disease other than AMD or DME in SE
   3. Patient with dilated eye(s)

Trial design

87 participants in 1 patient group

AMD Patients

Description:

OCT scan

Treatment:

Device: NOTAL OCT V2.5