Diabetic RetinopathyNCT05417152
Single In-Clinic Encounter With the Notal Vision Home OCT by DME Patients
An observational study of Diabetic Retinopathy, run by Notal Vision Inc. at 1 site in Israel.
Trial summary
In this clinical study the Notal Vision Home OCT (NVHO) Monitoring System will be used to evaluate the ability of patients diagnosed with DME to perform sequential self-images of their eyes with the self-operated NVHO device in a home simulated environment in the doctor's office. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- How many people
- 18 participants
- Where
- 1 siteIsrael
- Study dates
- 29 Jun 2022to 30 Mar 2023
- Phase
- Observational
- 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
Study population: The study population will include up to thirty (30) patients, with DR in at least one eye at the time of enrollment. All subjects will be enrolled at one (1) site in Israel. The subjects must meet all inclusion / exclusion criteria. Approximately 90% of the enrolled subjects should have at least one eye with DME at the time of enrollment.
Who may be able to join
- Ability to speak, read and understand Hebrew.
- Ability to understand and agree to contents of informed consent.
- Eighteen (18) years of age or older at the time of Informed Consent.
- Subjects diagnosed with DR (Diabetic Retinopathy) in at least one eye, with or without DME
- Best corrected Visual Acuity of 20/320 (6/96) or better in eyes participating at the study.
Who cannot join
- Subjects with dilated pupils.
- Subjects with other retinal disease requiring steroidal or anti-VEGF injections.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Repeated, In-Clinic, Self-Imaging by DME Patients Using the Notal Vision Home OCT
In this clinical study the Notal Vision Home OCT (NVHO) Monitoring System will be used to evaluate the ability of patients diagnosed with DME to perform sequential self-images of their eyes with the self-operated NVHO device in a home simulated environment in the doctor's office.
The study population will include up to 30 patients, with DR in at least one eye at the time of enrollment. All subjects will be enrolled at one site in Israel.
Read the detailed description
Office Visit NOTE: Any planned treatment for DME at the day of the study should be administered after completion of all study-related scans
At the enrollment Office Visit, the exams will be conducted in the following order:
- Patient will be informed concerning the study and sign the Informed Consent Form (ICF) prior to conduct of any study procedures.
- Following signing the ICF, subjects will be assigned a Subject ID by a designated staff at the clinical site.
- The following data will be collected for each study subject:
- Date of birth
- Gender
- Number and type of Anti-VEGF injections and last injection date
- Refraction correction 4. Snellen BCVA on both eyes on the day of the visit. 5. Eligible eye(s) of the subject will be scanned, non-dilated, with a Zeiss Cirrus OCT device with one (1) acceptable volume scan of each eye being obtained out of up to 3 attempts.
Scanning pattern to be used:
Macular cube, 6X6mm, 128 B-scans per volume scan 6. Eyes of the subject that meet all screening criteria will be enrolled. If both eyes of the subjects meet all screening criteria both eyes will be enrolled.
NOTE: Approximately 90% of the enrolled subjects should have at least one eye with DME at the time of enrollment.
- The following data will be collected for the study eye(s):
- Qualifying diagnosis for the study eye from the subject's medical record b. From the subject's medical record, the presence of other ophthalmic conditions including but not limited to: i. Cataract ii. Glaucoma iii. Dry Eye iv. Other macula findings, e.g., epi retinal membrane, macular hole, vitreo-macular traction (VMT)
Following confirmation of subject eligibility, subject will be placed in a room with the NVHO device which has been set up by a technician.
- The technician will register the subject using the touchscreen of the NVHO device using the subject's CRF number.
- The subject will perform a self-tutorial. The training flow begins with demonstration clips followed by a practice session. The training flow will be followed by a self-scan that the system uses as a calibration session.
- Following completion of the training and calibration session, the clinic technician shall set the device for self-scanning flow. The subject will perform four (4) unsupervised self-scans on each study eye with a rest period of ~2 minutes between self-scans.
- AEs, if applicable, will be collected. 6. Exit subject from the study
- Conditions
- Diabetic Retinopathy
- Medical subject headings
- Diabetic Retinopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
NVHO Total Retinal Fluid (TRF)
volume (nl) measured by NOA (automatic OCT analyzer)
Measured: 5 minutes
NVHO Intra-Retinal Fluid (IRF)
volume (nl) measured by NOA (automatic OCT analyzer)
Measured: 5 minutes
NVHO Sub-Retinal Fluid (SRF)
volume (nl) measured by NOA (automatic OCT analyzer)
Measured: 5 minutes
Zeiss Cirrus OCT Total Retinal Fluid (TRF)
volume (nl) measured by a human reader
Measured: 10 minutes
Zeiss Cirrus OCT Intra-Retinal Fluid (IRF)
volume (nl) measured by a human reader
Measured: 10 minutes
Zeiss Cirrus OCT Sub-Retinal Fluid (SRF)
volume (nl) measured by a human reader
Measured: 10 minutes
Scanning session completion status
complete/incomplete
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start29 Jun 2022
- Primary completion30 Nov 2022
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Notal Vision Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417152
- Sponsor's protocol ID
- C2021.003
- Status last verified
- Jun 2022
- First submitted
- 9 Jun 2022
- 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
- Evaluation of Repeated, In-Clinic, Self-Imaging by DME Patients Using the Notal Vision Home OCT
- ClinicalTrials.gov ID
- NCT05417152
- Acronym / sponsor ID
- C2021.003
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Notal Vision Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 14 Jun 2022 (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.
In this clinical study the Notal Vision Home OCT (NVHO) Monitoring System will be used to evaluate the ability of patients diagnosed with DME to perform sequential self-images of their eyes with the self-operated NVHO device in a home simulated environment in the doctor's office.
The study population will include up to 30 patients, with DR in at least one eye at the time of enrollment. All subjects will be enrolled at one site in Israel.
Detailed description
Office Visit NOTE: Any planned treatment for DME at the day of the study should be administered after completion of all study-related scans
At the enrollment Office Visit, the exams will be conducted in the following order:
- Patient will be informed concerning the study and sign the Informed Consent Form (ICF) prior to conduct of any study procedures.
- Following signing the ICF, subjects will be assigned a Subject ID by a designated staff at the clinical site.
- The following data will be collected for each study subject:
- Date of birth
- Gender
- Number and type of Anti-VEGF injections and last injection date
- Refraction correction 4. Snellen BCVA on both eyes on the day of the visit. 5. Eligible eye(s) of the subject will be scanned, non-dilated, with a Zeiss Cirrus OCT device with one (1) acceptable volume scan of each eye being obtained out of up to 3 attempts.
Scanning pattern to be used:
Macular cube, 6X6mm, 128 B-scans per volume scan 6. Eyes of the subject that meet all screening criteria will be enrolled. If both eyes of the subjects meet all screening criteria both eyes will be enrolled.
NOTE: Approximately 90% of the enrolled subjects should have at least one eye with DME at the time of enrollment.
- The following data will be collected for the study eye(s):
- Qualifying diagnosis for the study eye from the subject's medical record b. From the subject's medical record, the presence of other ophthalmic conditions including but not limited to: i. Cataract ii. Glaucoma iii. Dry Eye iv. Other macula findings, e.g., epi retinal membrane, macular hole, vitreo-macular traction (VMT)
Following confirmation of subject eligibility, subject will be placed in a room with the NVHO device which has been set up by a technician.
- The technician will register the subject using the touchscreen of the NVHO device using the subject's CRF number.
- The subject will perform a self-tutorial. The training flow begins with demonstration clips followed by a practice session. The training flow will be followed by a self-scan that the system uses as a calibration session.
- Following completion of the training and calibration session, the clinic technician shall set the device for self-scanning flow. The subject will perform four (4) unsupervised self-scans on each study eye with a rest period of ~2 minutes between self-scans.
- AEs, if applicable, will be collected. 6. Exit subject from the study
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include up to thirty (30) patients, with DR in at least one eye at the time of enrollment. All subjects will be enrolled at one (1) site in Israel. The subjects must meet all inclusion / exclusion criteria. Approximately 90% of the enrolled subjects should have at least one eye with DME at the time of enrollment.
Key inclusion criteria (5 listed)
- Ability to speak, read and understand Hebrew.
- Ability to understand and agree to contents of informed consent.
- Eighteen (18) years of age or older at the time of Informed Consent.
- Subjects diagnosed with DR (Diabetic Retinopathy) in at least one eye, with or without DME
- Best corrected Visual Acuity of 20/320 (6/96) or better in eyes participating at the study.
Key exclusion criteria (2 listed)
- Subjects with dilated pupils.
- Subjects with other retinal disease requiring steroidal or anti-VEGF injections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NVHO Total Retinal Fluid (TRF)
Time frame: 5 minutes
volume (nl) measured by NOA (automatic OCT analyzer)
NVHO Intra-Retinal Fluid (IRF)
Time frame: 5 minutes
volume (nl) measured by NOA (automatic OCT analyzer)
NVHO Sub-Retinal Fluid (SRF)
Time frame: 5 minutes
volume (nl) measured by NOA (automatic OCT analyzer)
Zeiss Cirrus OCT Total Retinal Fluid (TRF)
Time frame: 10 minutes
volume (nl) measured by a human reader
Zeiss Cirrus OCT Intra-Retinal Fluid (IRF)
Time frame: 10 minutes
volume (nl) measured by a human reader
Zeiss Cirrus OCT Sub-Retinal Fluid (SRF)
Time frame: 10 minutes
volume (nl) measured by a human reader
Scanning session completion status
Time frame: 5 minutes
complete/incomplete
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by Notal Vision Inc. at 1 site 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 5 inclusion and 2 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 1 site 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?
NVHO Total Retinal Fluid (TRF) (time frame: 5 minutes). The study lists 7 primary outcomes in all. 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.