AMDNCT04078672
Retinal Imaging Using NOTAL-OCT V3.0
A study testing NOTAL-OCT V3.0 in people with AMD and DR, run by Notal Vision Ltd. at 2 sites in Israel.
Trial summary
The study will include up to 250 AMD patients and up to 30 DR patients. In Tel Aviv medical center up to 100 AMD/ 20 DR patients will be recruited; In Assuta HaShalom up to 100 AMD/10 DR patients will be recruited; In Bnei Zion medical center up to 50 AMD patients will be recruited. 4.1 Study population 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- NOTAL-OCT V3.0
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesIsrael
- Study dates
- 2 Dec 2019to 26 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Ability and agreement to give informed consent (IC) 2. Diagnosis of AMD or DR in SE by OCT 3. Ability to undergo OCT scans 4. VA of 20/400 (6/120) or better in study eye(s)
Who cannot join
- 1. Patient with dilated eye(s)
Trial locations and contacts
2 sites in 1 country.
About this study
The study will include up to 250 AMD patients and up to 30 DR patients. In Tel Aviv medical center up to 100 AMD/ 20 DR patients will be recruited; In Assuta HaShalom up to 100 AMD/10 DR patients will be recruited; In Bnei Zion medical center up to 50 AMD patients will be recruited.
4.1 Study population 1. AMD patients - intermediate and advanced AMD (with active or non-active CNV) 2. DR patients - with and without edema 4.2 Inclusion criteria
- Ability and agreement to give informed consent (IC)
- Diagnosis of AMD or DR in SE by OCT
- Ability to undergo OCT scans
- VA of 20/400 (6/120) or better in study eye(s)
4.3 Exclusion criteria
- Patient with dilated eye(s)
Read the detailed description
4.5.1 SCREENING VISIT:
For patients eligible to participate in the study, the following procedure will be done in the screening visit:
- Patient will sign the IC (Informed Consent) form
- Test the eligible eye(s) of the patient will be tested
- The following demographic and clinical data will be collected for each tested eye and will be registered in the CRF:
- Patient's DOB and gender.
- Patient's diagnosis in study eye(s), based on patient's medical record, including media opacity (e.g. cataract or corneal opacity, if exists).
- Examination to check habitual correction, pinhole VA and refraction. 4.5.2 OCT Visit 1: may take place on the same day as screening visit. For each eligible eye, testing will include:
- Refraction by auto-refractometer e. Commercial OCT scanning: i. Scanning pattern: Macular cube of at least 6mm (20 degrees); At least 40 B-scans per cube f. NOTAL-OCT V3.0 scanning: i. Scanning pattern Macular cube of the central 10 degrees of the macula At least 40 B-scans per cube ii. The patients will undergo an interactive tutorial that will teach the patient to self-operate the NOTAL-OCT V3.0 device. The tutorial will be done only once, using the eye with the better VA. iii. To check repeatability, image capturing phase will include up to 8 testing sessions, each ~2 minutes long. iv. Patients will rest for 5 minutes between sessions. v. Total examination time with NOTAL-OCT V3.0 is expected to be less than an hour. vi. In case of patient's fatigue during the testing procedure, examination session will be terminated. vii. The study staff will administer the NOTAL-OCT V3.0 "patient-experience" questionnaire at the 1st OCT Visit. 4.5.3 OCT Visits 2-6: For each eligible eye, imaging will include:
- Commercial OCT scanning: i. Scanning pattern: Macular cube of at least 6mm (20 degrees); At least 40 B-scans per cube b. NOTAL-OCT V3.0 scanning: i. Scanning pattern Macular cube of the central 10 degrees of the macula At least 40 B-scans per cube ii. Image capturing phase that will include up to 8 testing sessions, each a~2 minutes long. iii. Patients will rest for 5 minutes between sessions. iv. Total examination time with the NOTAL-OCT V3.0 is expected to be less than an hour.
- In case of patient's fatigue during the testing procedure, examination will be terminated.
- VA of eye(s) participating in the study. d. Clinical diagnosis of eye(s) participating in the study.
- Being tested
- NOTAL-OCT V3.0
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOTAL-OCT V3.0Procedure or surgery
Also called OCT scan
AMD and DR patients
| Study group | Role | What they receive |
|---|---|---|
| AMD | Experimental | NOTAL-OCT V3.0 scan Receives: Procedure: NOTAL-OCT V3.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the level of agreement between OCT images captured by NOTAL-OCT V3.0 and by a commercial OCT
The measurement of fluid as identified by an eye-care professional, in the central 10 degrees of the macula of DR patients.
Measured: Less then an hour
Secondary outcomes (3)
To evaluate the level of agreement between OCT images captured by NOTAL-OCT V3.0 and a by commercial OCT
The measurement of fluid as identified by an eye-care professional, in the central 10 degrees of the macula of DR patients.
Measured: Less then an hour
To evaluate repeatability
To evaluate the repeatability of the detection of fluid in images captured by NOTAL-OCT V3.0 in the central 10 degrees of the macula of AMD and DR patients.
Measured: Less then an hour
To evaluate the level of agreement between NOTAL-OCT V3.0 and a commercial OCT in the presence of fluid
The measurement of fluid as identified by an eye-care professional, in the central 10 degrees of the macula.
Measured: Less then an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start2 Dec 2019
- Primary completion30 Jan 2023
- Study completion26 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Notal Vision Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078672
- Sponsor's protocol ID
- NOTAL-OCT V3.0
- Status last verified
- Apr 2023
- First submitted
- 27 Aug 2019
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Imaging Using NOTAL-OCT V3.0
- ClinicalTrials.gov ID
- NCT04078672
- Acronym / sponsor ID
- NOTAL-OCT V3.0
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Notal Vision Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 26 Mar 2023 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will include up to 250 AMD patients and up to 30 DR patients. In Tel Aviv medical center up to 100 AMD/ 20 DR patients will be recruited; In Assuta HaShalom up to 100 AMD/10 DR patients will be recruited; In Bnei Zion medical center up to 50 AMD patients will be recruited.
4.1 Study population 1. AMD patients - intermediate and advanced AMD (with active or non-active CNV) 2. DR patients - with and without edema 4.2 Inclusion criteria
- Ability and agreement to give informed consent (IC)
- Diagnosis of AMD or DR in SE by OCT
- Ability to undergo OCT scans
- VA of 20/400 (6/120) or better in study eye(s)
4.3 Exclusion criteria
- Patient with dilated eye(s)
Detailed description
4.5.1 SCREENING VISIT:
For patients eligible to participate in the study, the following procedure will be done in the screening visit:
- Patient will sign the IC (Informed Consent) form
- Test the eligible eye(s) of the patient will be tested
- The following demographic and clinical data will be collected for each tested eye and will be registered in the CRF:
- Patient's DOB and gender.
- Patient's diagnosis in study eye(s), based on patient's medical record, including media opacity (e.g. cataract or corneal opacity, if exists).
- Examination to check habitual correction, pinhole VA and refraction. 4.5.2 OCT Visit 1: may take place on the same day as screening visit. For each eligible eye, testing will include:
- Refraction by auto-refractometer e. Commercial OCT scanning: i. Scanning pattern: Macular cube of at least 6mm (20 degrees); At least 40 B-scans per cube f. NOTAL-OCT V3.0 scanning: i. Scanning pattern Macular cube of the central 10 degrees of the macula At least 40 B-scans per cube ii. The patients will undergo an interactive tutorial that will teach the patient to self-operate the NOTAL-OCT V3.0 device. The tutorial will be done only once, using the eye with the better VA. iii. To check repeatability, image capturing phase will include up to 8 testing sessions, each ~2 minutes long. iv. Patients will rest for 5 minutes between sessions. v. Total examination time with NOTAL-OCT V3.0 is expected to be less than an hour. vi. In case of patient's fatigue during the testing procedure, examination session will be terminated. vii. The study staff will administer the NOTAL-OCT V3.0 "patient-experience" questionnaire at the 1st OCT Visit. 4.5.3 OCT Visits 2-6: For each eligible eye, imaging will include:
- Commercial OCT scanning: i. Scanning pattern: Macular cube of at least 6mm (20 degrees); At least 40 B-scans per cube b. NOTAL-OCT V3.0 scanning: i. Scanning pattern Macular cube of the central 10 degrees of the macula At least 40 B-scans per cube ii. Image capturing phase that will include up to 8 testing sessions, each a~2 minutes long. iii. Patients will rest for 5 minutes between sessions. iv. Total examination time with the NOTAL-OCT V3.0 is expected to be less than an hour.
- In case of patient's fatigue during the testing procedure, examination will be terminated.
- VA of eye(s) participating in the study. d. Clinical diagnosis of eye(s) participating in the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMD | Experimental | Procedure: NOTAL-OCT V3.0NOTAL-OCT V3.0 scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Ability and agreement to give informed consent (IC) 2. Diagnosis of AMD or DR in SE by OCT 3. Ability to undergo OCT scans 4. VA of 20/400 (6/120) or better in study eye(s)
Key exclusion criteria (1 listed)
- 1. Patient with dilated eye(s)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOTAL-OCT V3.0Also: OCT scanAMD and DR patients | Procedure or surgery | AMD |
Primary outcome
To evaluate the level of agreement between OCT images captured by NOTAL-OCT V3.0 and by a commercial OCT
Time frame: Less then an hour
The measurement of fluid as identified by an eye-care professional, in the central 10 degrees of the macula of DR patients.
3 secondary outcomes
To evaluate the level of agreement between OCT images captured by NOTAL-OCT V3.0 and a by commercial OCT
Time frame: Less then an hour
To evaluate repeatability
Time frame: Less then an hour
To evaluate the level of agreement between NOTAL-OCT V3.0 and a commercial OCT in the presence of fluid
Time frame: Less then an hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOTAL-OCT V3.0 in people with AMD and DR, run by Notal Vision Ltd. at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the level of agreement between OCT images captured by NOTAL-OCT V3.0 and by a commercial OCT (time frame: Less then an hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.