Single In-Clinic Encounter With the Notal Vision Home OCT
Completed
Conditions studied: Neovascular Age-related Macular Degeneration, Intermediate Age Related Macular Degeneration (Disorder)
In brief
this is a single In-Clinic Encounter With the Notal Vision Home OCT study. The study population will include up to 50 Age-related Macular Degeneration patients diagnosed with wet NV-AMD in at least one eye at the time of enrollment. All enrolled subjects should have at least one eye with active (wet) CNV (SRF and/or IRF) at the time of enrollment. All subjects will be enrolled at 1 site in the United States. in this study patients will be placed in a room with the Notal Vision Home OCT device and following a completion of a self tutorial will perform 3 unsupervised self-scans on each study eye (with a rest of \~5 minutes between self-scans). at the end of the testing sessions, the subject will be asked to complete subject user questionnaire.
Key facts
- Study ID
- NCT04642183
- Run by
- Notal Vision Inc.
- People needed
- 70
- Starts
- 2020-11-16
- Expected to finish
- 2021-09-30
- Last updated by the study team
- 2021-12-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Ability to speak, read and understand English.
- Ability to understand and agree to contents of informed consent either in writing or verbally.
- Eighteen (18) years of age or older at the time of Informed Consent.
- AMD patients diagnosed with wet NV-AMD in at least one eye (ie, with SRF, and/or IRF).
- Fellow eye with NV-AMD (with or without fluid) or intermediate AMD.
- Best corrected Visual Acuity of 20/320 or better in eyes participating at the study.
You may not qualify if…
- Subjects with dilated pupils.
- Any other retinal disease requiring steroidal or anti-VEGF injections.
Where it is running
- Elman Retina Group, PA — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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