Status:
COMPLETED
The Evaluation of the Agreement Between the NVHO in the Automatic Fluid Quantification and Cirrus OCT
Lead Sponsor:
Notal Vision Inc.
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
18+ years
Brief Summary
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 t...
Detailed Description
Screening will include refraction, best corrected visual acuity and Cirrus OCT. Subjects will receive a general overview of the self-operation of the NVHO system. The general overview will include wri...
Eligibility Criteria
Inclusion
- 1\. Ability to speak, read and understand English. 2. Ability to understand and agree to contents of informed consent either in writing or verbally.
- 3\. Adult diagnosed with NV-AMD in at least one eye with or without fluid based on the subject's medical record.
- 4\. 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 12 2023
Estimated Enrollment :
386 Patients enrolled
Trial Details
Trial ID
NCT05202587
Start Date
November 10 2021
End Date
January 12 2023
Last Update
February 15 2023
Active Locations (5)
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1
Brian Joondeph
Lakewood, Colorado, United States, 80228
2
Florida Retina Institute, PA
Orlando, Florida, United States, 32806
3
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45242
4
Tennessee Retina, PC
Nashville, Tennessee, United States, 37203