Home Retinal Imaging Using NOTAL-OCT V3.0

The study will include up to 30 AMD patients, recruited by two medical centers, Tel-Aviv medical center and Assuta Hashalom medical center. At the screening visit, the patients will be imaged in their tested, eligible eye(s), using a commercial Zeiss Cirrus or Heidelberg Spectralis OCT.

Study Overview

• Status: Completed
• Conditions: A. AMD Patients, Where at Least One Eye is With Active CNV, Presenting Retinal Fluid at the Enrolment Visit, Undergoing Active Anti-VEGF Treatment

Detailed Description

Screening visit:

For patients eligible to participate in the study, the following procedure will be done in the "screening visit" at the clinic:

1. Patient will sign the IC (Informed Consent) form

2. The following demographic and clinical data will be collected and registered in the CRF:

   1. Patient's DOB and gender.
   2. Patient's diagnosis in study eye(s), based on patient's medical record, including media opacity (e.g. cataract or corneal opacity, if exists).
   3. Bio-microscopy testing.
   4. Refraction correction by an optometrist.
   5. Habitual Snellen visual acuity
   6. Commercial OCT scanning using Zeiss Cirrus or Heidelberg Spectralis.

OCT scanning pattern:

• Macular cube of at least 6X6mm (20 degrees)
• At least 40 B-scans per cube

Setup and tutorial home visit:

The device will be delivered to the patient's home with a setup guide attached to the package. The patient will read the setup guide instructions, unpack the device, place it on a table and connect it to a power supply. Upon first usage a tutorial clip, explaining how to operate the device and self-image the eyes, will be automatically displayed on the device's external screen. Following the tutorial patients will be instructed to scan their study eye(s). A remote support service, provided by the sponsor, will be available as needed. Its phone number will be given to the patient and will be attached to the device's base.

Daily home testing:

For each eligible eye, the following procedure will be done in the "Daily testing" at the patients' homes:

1. The patients will be requested to self-scan their study eye(s) daily, using the NOTAL-OCT V3.0..
2. The patient will be able call the sponsor's remote support service, during working hours, for assistance in case of questions or problems regarding the operation the NOTAL-OCT V3.0 device.

Exit visit:

For each eligible eye, the following procedure will be done in the "Exit visit" at the clinic:

1. Bio-microscopy testing.
2. Refraction correction by an optometrist.
3. Habitual Snellen visual acuity
4. Commercial OCT scanning using Zeiss Cirrus or Heidelberg Spectralis.

OCT scanning pattern:

• Macular cube of at least 6X6mm (20 degrees)

• At least 40 B-scans per cube NOTAL-OCT V3.0 Scanning.

  6.Patient's experience questionnaire

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • TLV Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

AMD patients, where at least one eye is with active CNV, presenting retinal fluid at the enrolment visit, undergoing active anti-VEGF treatment

Description

Inclusion Criteria:

1. Ability and willingness to give informed consent (IC)
2. 18 years of age or older at the time of IC
3. Tested eye(s) diagnosed with AMD
4. Visual acuity of 20/400 Snellen (6/120) or better in the study eye
5. At least one eye is with active CNV, presenting retinal fluid at the enrolment visit, undergoing active anti-VEGF treatment
6. Ability to undergo OCT testing

Exclusion Criteria:

NA

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To describe the dynamics of retinal fluid	To describe the dynamics of retinal fluid in eyes undergoing anti-VEGF therapy as manifested in self-operated OCT in daily home testing	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate patient experience when self-operating the Notal-OCT V3.0.	by a patient experience questionnaire.	30 days
E. To evaluate the level of agreement between OCT images captured by Notal-OCT V3.0 and a commercial OCT	E. To evaluate the level of agreement between OCT images captured by Notal-OCT V3.0 and a commercial OCT, for the presence of fluid, in the central 10 degrees of the macula, at screening and exit visits.	30 days

Collaborators and Investigators

• Sponsor: Notal Vision Ltd.
• Investigators: Principal Investigator: michaela Glodstein, Dr, Tel Aviv Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2020
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): March 28, 2023

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Home Imaging using NOTAL-OCT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No