NOTAL-OCT V.2.5 vs Commercial OCT in AMD Patients
NCT03969303 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 287
Last updated 2020-11-12
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.
Conditions
- AMD - Age-Related Macular Degeneration
- Diabetic Macular Edema
Interventions
- DEVICE
-
Notal Vision Optical Coherence Tomography Device Version 2.5 (NOTAL-OCT V2.5)
OCT SCAN
Sponsors & Collaborators
-
Elman Retina Group
collaborator OTHER -
Notal Vision Ltd.
lead INDUSTRY
Principal Investigators
-
Michael Elman · Michael Elman, M.D. 9114 Philadelphia Rd #310 Baltimore, Maryland 21237
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-20
- Primary Completion
- 2019-07-11
- Completion
- 2019-10-04
Countries
- United States
Study Locations
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