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

NCT05745116 | Unknown FDA Device

• 1 other identifier: C2022.001
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

Brief 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

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (4)

• Evaluate subjects' ability to perform multiple OCT self-scanning following a self-tutorial on the Notal Vision Home OCT (NVHO)

  % of completion a self-imaging session

  within 2 hours of an office visit

• Evaluate the repeatability of the Notal OCT Analyzer (NOA) automatic fluid volume quantification in volume scan from self-scanning with the NVHO in the central 10 degrees of the macula of Diabetic Retinopathy (DR) patients

  NVHO volume scan Total Retinal Fluid (TRF) amount measured by NOA, NVHO volume scan Intra-Retinal Fluid (IRF) amount measured by NOA, NVHO volume scan Sub-Retinal Fluid (SRF) amount measured by NOA

  within 2 hours of an office visit

• Compare fluid quantification in images from NVHO and a commercial OCT

  Compare fluid quantification in images captured by the NVHO, as calculated by the Notal OCT Analyzer (NOA) algorithm and the fluid quantification in images captured by a commercial OCT, as marked by a human reader - in the central 10 degrees of the macula of DR patients Zeiss Cirrus or Spectralis OCT volume scan Total Retinal Fluid (TRF), Intra-Retinal Fluid (IRF), Sub-Retinal Fluid (SRF) amount measured by a human reader

  within 2 hours of an office visit

• Scanning session completion status - complete/incomplete

  within 2 hours of an office visit

Secondary Outcomes (1)

• Safety Endpoints

  within 2 hours of an office visit

Interventions

Notal Vision Home OCT DEVICE

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include up to one hundred fifty (150) patients, with DR in at least one eye at the time of enrollment. Subjects will be enrolled at up to three (3) sites in the United States. The subjects must meet all inclusion / exclusion criteria. Approximately 90% of the enrolled subjects should have at least one eye with DME at the time of enrollment.

You may qualify if:

• Ability to speak, read and understand English.
• Ability to agree, understand and sign the informed consent form.
• Eighteen (18) years of age or older at the time of Informed Consent.
• Subjects diagnosed with DR (Diabetic Retinopathy) in at least one eye, with or without DME
• Best corrected Visual Acuity of 20/320 (6/96) or better in eyes participating at the study.

You may not qualify if:

• Subjects with dilated pupils.
• Subjects with other retinal disease requiring steroidal or anti-VEGF injections

Sponsors & Collaborators

• Notal Vision Inc.: lead

Study Sites (3)

Elman Retina Group, PA

Baltimore, Maryland, 21237, United States

RECRUITING

The Retina Group of Washington

Fairfax, Virginia, 22031, United States

RECRUITING

Wagner Kapoor Research Institute

Norfolk, Virginia, 23502, United States

RECRUITING

Central Study Contacts

Elizabeth Leicht

CONTACT

830-285-2508; elizabeth@dynamictrialconsultants.com

Theresa Landry

CONTACT

theresa.landry@notalvision.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: February 27, 2023
• Study Start: November 7, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: February 27, 2023

Record last verified: 2023-01

Locations

US (3)