Recruiting

Notal Vision Home OCT

Sponsor:

Notal Vision Inc.

Code:

NCT05650047

Conditions

Retinal Neovascularization

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

During the last 25 years, OCT has become one of the most common imaging technologies used to diagnose and monitor retinal diseases, including AMD. The OCT self-imaging capabilities of the Notal Vision Home OCT (NVHO) system for retinal fluid visualization in the central 10 degrees were validated during several prospective clinical studies1,2,3,4,5. This study is designed to evaluate the retinal fluid exposure of eyes with NV-AMD, using the NVHO system to guide therapy.

Conditions

Retinal Neovascularization

Study ID

NCT05650047

Start date

Sep 9, 2022

Status verified date

Dec, 2022

Completion date

Sep 9, 2023

Anticipated

Primary completion date

Jul 26, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 1. Ability to speak and understand English with fluency. 2. Ability to understand and agree to contents of informed consent either in writing or verbally. 3. At least 55 years of age on date of Screening Visit. 4. Diagnosed with NV-AMD in at least one eye and initiation of anti-VEGF treatment in that eye. 5. Visual Acuity of 20/320 or better. 6. Available and willing to conduct daily self-imaging at home for the duration of the trial.

Exclusion Criteria:

1. Any other retinal disease in the study eye requiring steroidal or anti-VEGF injections (anti-VEGF injections during the study period must be for NV-AMD).
2. Subject's schedule not conducive to completing daily tests at home with the Notal Home OCT device for the duration of the study. -

Study Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Area under the fluid volume trajectory between treatments (nl-days) during the study period by fluid type (IRF/SRF/TRF) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Eileen Lauer

7736271652elauer@notalvision.com

Taylor Mygatt

tmygatt@notalvision.com

Locations

Ophthalmic Cons. of Boston

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Alison Nowak

617-314-2694anowak@eyeboston.com

Principal Investigator:

Jeffrey Heier, MD

Pepose Vision Institute

Recruiting

Saint Louis, Missouri, United States, 63017

Contacts

Roxanne Canter

636-534-5126rcanter@midwestvrf.org

Principal Investigator:

Anthony De Beus, MD

Palmetto Retina Center

Recruiting

Florence, South Carolina, United States, 29501

Contacts

Courtney Sease

csease@palmettoretina.com

Principal Investigator:

Lloyd Clark, MD

More Information

Sponsor

Notal Vision Inc.

Last update posted

May 22, 2023

Last verified

Dec, 2022

Keywords

  • AMD self-scanning Home-OCT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Notal Vision Inc. on 2023-05-22.