NCT04642183|CompletedDMC
Single In-Clinic Encounter With the Notal Vision Home OCT
Evaluation of Repeated, In-Clinic, Self-Imaging by NV-AMD Patients Using the Notal Vision Home OCT
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Evaluation of Repeated, In-Clinic, Self-Imaging by NV-AMD Patients Using the Notal Vision Home OCT
Sponsor study identifier
observational
70
1 country
1
Study Start
November 16, 2020
Actual (reported)Primary Completion
August 24, 2021
Actual (reported)Study Completion
September 30, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 11, 2020
Actual (reported)November 16, 2020
Actual (reported)November 24, 2020
Actual (reported)August 24, 2021
Actual (reported)September 30, 2021
Actual (reported)Percentage of subjects who completed self-scanning following a self-tutorial.
Percentage of subjects who were able to perform a full self-scanning and generate a retinal volume scan.
5-10 minutes
Percentage of eyes that performed 4 self-scans with the same fluid status
Percentage of eyes that performed 4 self-scans, where their fluid status (fluid present/absent) is identical based both human reader and the Notal OCT Analyzer (NOA) artificial-intelligence (AI) module.
About 30 min - upon completion of the study visit
Agreement between the Cirrus OCT and the NVHO device in detecting fluid in the central 3x3mm of the macula.
About 30 min - upon completion of the study visit
Summary of subject questionnaire results.
For the multi-choice questions - the average score (1-5) for each question. For open questions - collect the user's feedback for future improvements of the device
5-10 minutes
The study population will include up to fifty (50) AMD patients diagnosed with wet NV-AMD in at least one eye at the time of enrollment. All subjects will be enrolled at one (1) site in the United States. Patients must meet all inclusion / exclusion criteria. All enrolled subjects should have at least one eye with active (wet) CNV (SRF and/or IRF) at the time of enrollment.
Elman Retina Group, PA
Baltimore, Maryland, 21237, United States
Michael Elman, MD
Michael Elman, M.D. 9114 Philadelphia Rd #310 Baltimore, Maryland 21237
70 participants (actual enrollment reported by the registry).
First Submitted
November 11, 2020
First Posted
November 24, 2020
Study Start
November 16, 2020
Actual (reported)Effect of Intravitreally Administered AIV007 in Subjects With Neovascular Age-Related Macular Degeneration
Contact the study team to confirm eligibility.
Primary Completion
August 24, 2021
Actual (reported)Study Completion
September 30, 2021
Actual (reported)Last Updated
December 23, 2021
Record last verified: 2021-06
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Source: ClinicalTrials.gov.
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