Status:
UNKNOWN
Home OCT Fluid Visualization Agreement Study
Lead Sponsor:
Notal Vision Inc.
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
55+ years
Brief Summary
This is a single arm study of home monitoring with the NVHO for 5 weeks with office visits at enrollment, Week 1 and Week 5 (Exit Visit) and, when applicable, Interim Visit(s) triggered by ongoing rev...
Detailed Description
The objectives of this study are to (1) evaluate the agreement, via positive percent agreement (PPA) and negative percent agreement (NPA), between OCT images captured by the NVHO and by the Zeiss Cirr...
Eligibility Criteria
Inclusion
- Subjects must have the ability to speak, read and understand English.
- Ability to understand and agree to contents of informed consent either in writing or verbally.
- Age 55 or older at the Enrollment Visit.
- Adults diagnosed with NV-AMD in at least one eye based on the subject's medical record. Fellow eyes diagnosed with dry AMD may be included as secondary eyes to a primary eye diagnosed with NV-AMD.
- Note: eyes whit other pathologies including pseudocysts, outer retinal tabulations, pigments epithelial, detachments, hemorrhage, sub retinal hyper reflective material (SHRM), geographic atrophy and sub RPE, hypo reflective areas can be enrolled.
- Best corrected Visual Acuity of 20/320 or better in eyes that will perform self-imaging.
- Available and willing to set up a device and conduct self-imaging at their home.
Exclusion
- Anti-VEGF treatment for NV-AMD in the study eye(s) at the screening visit.
- Any other retinal disease requiring steroidal or anti-VEGF injections.
- Prior experience with the NVHO device.
Key Trial Info
Start Date :
June 17 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 30 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04907409
Start Date
June 17 2021
End Date
August 30 2022
Last Update
March 9 2022
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Georgia Retina
Marietta, Georgia, United States, 30060
2
Retina Associates of Kentucky
Lexington, Kentucky, United States, 40509
3
Elman Retina Group, P.A.
Glen Burnie, Maryland, United States, 21061
4
Ophthalmic Cons. of Boston
Boston, Massachusetts, United States, 02114