The Evaluation of the Agreement Between the NVHO in the Automatic Fluid Quantification and Cirrus OCT

Completed

Conditions studied: Neovascular Age-related Macular Degeneration

In brief

This multi-center study will enroll Adult subjects diagnosed with neo-vascular age-related macular degeneration (NV-AMD) in at least one eye at the time of enrollment. the subject study duration for this study is one day (2-3 hours). Each study site will have two NVHO devices and one Cirrus 5000 and the patients will be scand on the two NVHO devices and one Cirrus device as a part of the study flow. At the Study Visit, fluid must be present in approximately 280 study eyes and fluid must be absent from 20 study eyes. Each subject will only have one study eye. The fluid status will be determined by the investigator while reviewing an acceptable screening Cirrus OCT volume scan.

Key facts

Study ID

NCT05202587

Run by

Notal Vision Inc.

People needed

386

Starts

2021-11-10

Expected to finish

2023-01-12

Last updated by the study team

2023-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Ability to speak, read and understand English. 2. Ability to understand and agree to contents of informed consent either in writing or verbally.
• Adult diagnosed with NV-AMD in at least one eye with or without fluid based on the subject's medical record.
• Best corrected Visual Acuity of 20/320 or better in the study eye. 5. Available and willing to conduct Cirrus imaging and NVHO self-imaging in a clinic environment.
• Note: Eyes with other pathologies including pseudocysts, outer retinal tubulations, pigment epithelial detachments, hemorrhage, subretinal hyper-reflective material (SHRM), geographic atrophy, sub-retinal pigment epithelium (RPE) hypo-reflective areas, epiretinal membrane (ERM), macular hole, and hyperreflective retinal spots (Foci) can be enrolled.

You may not qualify if…

• 1. Any other retinal disease requiring steroid or anti-VEGF injections. 2. Cirrus scan during screening with Signal Strength <6. 3. Dry AMD in study eye.

Where it is running

• Brian Joondeph — Lakewood, Colorado, United States
• Florida Retina Institute, PA — Orlando, Florida, United States
• Cincinnati Eye Institute — Cincinnati, Ohio, United States
• Tennessee Retina, PC — Nashville, Tennessee, United States
• Strategic Clinical Research Group — Willow Park, Texas, United States

Full record on ClinicalTrials.gov

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