Clinical trial NCT04241198: Home Retinal Imaging Using NOTAL-OCT V3.0
Official title: Home Retinal Imaging Using NOTAL-OCT V3.0
Study type: OBSERVATIONAL
Overall 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
Lead sponsor: Notal Vision Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: To describe the dynamics of retinal fluid
timeFrame: 30 days
Secondary outcomes:
measure: To evaluate patient experience when self-operating the Notal-OCT V3.0.
timeFrame: 30 days
measure: E. To evaluate the level of agreement between OCT images captured by Notal-OCT V3.0 and a commercial OCT
timeFrame: 30 days
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: TLV Medical Center
Study officials:
affiliation: Tel Aviv Medical Center
name: michaela Glodstein, Dr
role: PRINCIPAL_INVESTIGATOR
References: