Home OCT Repeatability and Reproducibility of Automatic Fluid Quantification Study

NCT05281042 | Completed DMC

• 1 other identifier: C2021.002
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The study will enroll up to 30 AMD patients diagnosed with NV-AMD in at least one eye at the time of enrollment. At the Study Visit, fluid must be present in at least one eye of the subjects. If only one eye qualifies for enrollment, that will be assigned as the study eye. If both eyes are eligible, the study eye will be assigned according to a randomization schedule. Only one eye of each subject will be enrolled in the study. All subjects will be enrolled at 1 site in the United States. Subjects must meet all inclusion and no exclusion criteria.

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (6)

• Notal Home OCT Total Retinal Fluid (TRF) amount measured by NOA

  volume \[nl\] of the TRF

  5 minutes

• Notal Home OCT Intra-Retinal Fluid (IRF) amount measured by NOA

  volume \[nl\] of the IRF

  5 minutes

• Notal Home OCT Sub-Retinal Fluid (SRF) amount measured by NOA

  volume \[nl\] of the SRF

  5 minutes

• Zeiss Cirrus OCT Total Retinal Fluid (TRF) amount measured by a human reader

  volume \[nl\] of the TRF

  5 minutes

• Zeiss Cirrus OCT Intra-Retinal Fluid (IRF) amount measured by a human reader

  volume \[nl\] of the IRF

  5 minutes

• Zeiss Cirrus OCT Sub-Retinal Fluid (SRF) amount measured by a human reader

  volume \[nl\] of the SRF

  5 minutes

Secondary Outcomes (1)

• Subjects who completed self-scanning on the Notal Home OCT, following a self-tutorial.

  5 minuts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

30 AMD patients diagnosed with NV-AMD in at least one eye at the time of enrollment. At the Study Visit, fluid must be present in at least one eye of the subjects. If only one eye qualifies for enrollment, that will be assigned as the study eye. If both eyes are eligible, the study eye will be assigned according to a randomization schedule. Only one eye of each subject will be enrolled in the study. All subjects will be enrolled at one 1 site in the United States.

You may qualify if:

• Ability to speak, read and understand English.
• Ability to understand and agree to contents of informed consent in writing or verbal.
• Adult diagnosed with NV-AMD in at least one eye based on the subject's medical record.
• Fluid presence in the study eye per the PI review of Screening commercial OCT.
• Best corrected Visual Acuity of 20/320 or better in the study eye.
• Available and willing to conduct self-scanning in the office

You may not qualify if:

• Any other retinal disease requiring steroidal or anti-VEGF injections.
• Dilated pupils

Sponsors & Collaborators

• Notal Vision Inc.: lead

Study Sites (1)

Elman Retina Group

Glen Burnie, Maryland, 21061, United States

Location

Study Officials

• Gidi Benyamini

  Notal vision Druyanov 5, Tel Aviv

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: March 6, 2022
• First Posted: March 15, 2022
• Study Start: September 13, 2021
• Primary Completion: November 30, 2021
• Study Completion: January 5, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-02

Locations

US (1)