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Home OCT Fluid Visualization Agreement Study

NCT04907409 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2022-03-09

No results posted yet for this study

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 review by the Reading Center. The study will enroll subjects diagnosed with NV-AMD in at least one eye with attention to the proportion of eyes with IRF and/or SRF. The enrolled eligible subjects will be instructed to self-image the study eye(s) once daily for 5 weeks using a NVHO device at home with scheduled in-office examinations at Week 1, Week 5 and Interim Visits, when applicable, with additional in-office Cirrus volume scans acquired at these office visits. The self-imaging data on the NVHO will be automatically uploaded to the Notal Health Cloud and from there the reconstructed volume scans will sent to the study database.

Conditions

  • Neovascular Age-related Macular Degeneration

Sponsors & Collaborators

  • Notal Vision Inc.

    lead INDUSTRY

Principal Investigators

  • Gidi Benyamini, MD · Druyanov 5, Tel Aviv Israel

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-17
Primary Completion
2022-07-30
Completion
2022-08-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04907409 on ClinicalTrials.gov