Single In-Clinic Encounter With the Notal Vision Home OCT

NCT04642183 | Completed DMC

• 1 other identifier: C2020.005
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neovascular Age-related Macular Degeneration; Intermediate Age Related Macular Degeneration (Disorder)

Outcome Measures

Primary Outcomes (4)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

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.

Sponsors & Collaborators

• Notal Vision Inc.: lead

Study Sites (1)

Elman Retina Group, PA

Baltimore, Maryland, 21237, United States

Location

Study Officials

• Michael Elman, MD

  Michael Elman, M.D. 9114 Philadelphia Rd #310 Baltimore, Maryland 21237

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 24, 2020
• Study Start: November 16, 2020
• Primary Completion: August 24, 2021
• Study Completion: September 30, 2021
• Last Updated: December 23, 2021

Record last verified: 2021-06

Locations

US (1)