Evaluation of Repeated, In-Clinic, Self-Imaging by DME Patients Using the Notal Vision Home OCT

UnknownOBSERVATIONAL
Enrollment

150

Participants

Timeline

Start Date

November 7, 2022

Primary Completion Date

July 31, 2023

Study Completion Date

July 31, 2023

Conditions
Diabetic Macular Edema
Interventions
DEVICE

Notal Vision Home OCT

Optical Coherence Tomography (OCT) was originally developed in 1991 as a non-invasive imaging technology to generate cross-sectional imagery of ocular tissues in vivo1. Cross-sectional visualization of the retina has proven to be a valuable tool in the identification and assessment of structural abnormalities that are not visible with ophthalmoscopic or biomicroscopic examination. OCT has become eye care professionals' leading diagnostic tool in the detection, diagnosis and treatment of retinal diseases and conditions, including age-related macular degeneration (AMD), Diabetic Macular Edema (DME), and Retina Vein Occlusion (RVO). Notal Vision, Inc. (Manassas, VA) is developing a Home Optical Coherence Tomography (OCT) System to allow OCT images to be captured on an OCT device placed in the patients' homes for daily scanning of eyes diagnosed with DME. This Home OCT allows visualization of retinal fluid in the central 10 degrees and is currently for investigational use only.

Trial Locations (3)

21237

RECRUITING

Elman Retina Group, PA, Baltimore

22031

RECRUITING

The Retina Group of Washington, Fairfax

23502

RECRUITING

Wagner Kapoor Research Institute, Norfolk

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Notal Vision Inc.

INDUSTRY