Recruiting

Notal Vision Home OCT

Sponsor:

Notal Vision Inc.

Code:

NCT05745116

Conditions

Diabetic Macular Edema

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Notal Vision Home OCT

Study Details

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

Study ID

NCT05745116

Start date

Nov 7, 2022

Status verified date

Jan, 2023

Completion date

Jul 31, 2023

Anticipated

Primary completion date

Jul 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Evaluate subjects' ability to perform multiple OCT self-scanning following a self-tutorial on the Notal Vision Home OCT (NVHO) [ Time Frame: 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 [ Time Frame: within 2 hours of an office visit ]
  • Compare fluid quantification in images from NVHO and a commercial OCT [ Time Frame: within 2 hours of an office visit ]
  • Scanning session completion status - complete/incomplete [ Time Frame: within 2 hours of an office visit ]

Central Contacts and Locations

Central contacts

Elizabeth Leicht

830-285-2508elizabeth@dynamictrialconsultants.com

Theresa Landry

theresa.landry@notalvision.com

Locations

Elman Retina Group, PA

Recruiting

Baltimore, Maryland, United States, 21237

Contacts

JoAnn Starr

elman@elmanretina.com

410) 686-3000Starr@elmanretina.com

Principal Investigator:

Michael Elman, MD

The Retina Group of Washington

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

(703) 564-7519hahluwalia@rgw.com

Wagner Kapoor Research Institute

Recruiting

Norfolk, Virginia, United States, 23502

Contacts

Chris Riebling, MD

kkapoor@wagnerkapoor.com

757-390-2433criebling@wagnerkapoor.com

More Information

Sponsor

Notal Vision Inc.

Last update posted

Feb 27, 2023

Last verified

Jan, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Notal Vision Inc. on 2023-02-27.