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

NCT05745116 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2023-02-27

No results posted yet for this study

Summary

Evaluation of Repeated, In-Clinic, Self-Imaging by DME Patients Using the Notal Vision Home OCT The purpose of this study is to collect data on the NVHO device at up to three sites.

Conditions

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.

Sponsors & Collaborators

  • Notal Vision Inc.

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-07
Primary Completion
2023-07-31
Completion
2023-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05745116 on ClinicalTrials.gov