AMD Population - Intermediate or Advanced AMDNCT03270865
Usability and Ergonomic Evaluation of Self-Positioning System for Retinal Imaging
A study testing PAF (Positioning And Fixation device) in people with AMD Population - Intermediate or Advanced AMD and DR Population- With or Without Diabetic Macular Edema, run by Notal Vision Ltd. at 1 site in Israel.
Trial summary
The purpose of the study "Usability and Ergonomic Evaluation of Self-Positioning System for Retinal Imaging" is to enable self-operation of a monitoring device in home-simulated environment Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- AMD Population - Intermediate or Advanced AMD, DR Population- With or Without Diabetic Macular Edema
- What is being tested?
- PAF (Positioning And Fixation device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Sep 2017to 30 Sep 2018
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65
- Able to understand and sign the informed consent form
- Ability to communicate verbally
- AMD (interim and advanced) or diabetic retinopathy (with and without DME)
Who cannot join
- Visual acuity >=20/200 in the better eye
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study "Usability and Ergonomic Evaluation of Self-Positioning System for Retinal Imaging" is to enable self-operation of a monitoring device in home-simulated environment
Read the detailed description
One of the main challenges in developing a retinal imager is to design it to be self-operated by elderly patients in their home setting The study's objective is to explore ergonomic solutions that will allow the user to perform imaging on their own. The study will be done in a home-simulated environment using a dedicated ergonomic system (termed "PAF" - Positioning And Fixation system) that stimulates the retinal imager and enables to record the tested subject using standard cameras. The prototype doesn't include the retinal imager and does not include any imaging capabilities aside from standard means of photography Subjects will be evaluating for positioning accuracy and comfort by comparing different methods. Pupil position will be recorded using commercial off the shelf cameras when the subject is performing simple ergonomic tasks while looking at a screen presenting images.
- Conditions
- AMD Population - Intermediate or Advanced AMD, DR Population- With or Without Diabetic Macular Edema
- Being tested
- PAF (Positioning And Fixation device)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAF (Positioning And Fixation device)Device
Up to 60 Subjects will be evaluating for positioning accuracy and comfort by comparing different methods utilizing the PAF device. Some methods of positioning will be applied and compare for each usability factor X, Y, Z location, and fixation.
The patient will be evaluated before pupil dilation. VA and ophthalmic diagnoses will be recorded.
Pupil position will be recorded using 3 commercial off the shelf cameras when the subject is performing simple ergonomic tasks while looking at a screen presenting images. Each testing session will be limited 20 min long. Subjects will be able to rest within the testing session if required. Total session time per patient will not exceed 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Usability and Ergonomic Evaluation of Self-Positioning System | Experimental | Not described Receives: Device: PAF (Positioning And Fixation device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
spatial location of the pupil, during an eye examination
documentation of pupil location by a camera
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start30 Sep 2017
- Primary completion1 Feb 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMD Population - Intermediate or Advanced 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT03270865
- Sponsor's protocol ID
- Notal U-001 V. 1.0
- Status last verified
- Jun 2019
- First submitted
- 15 Aug 2017
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability and Ergonomic Evaluation of Self-Positioning System for Retinal Imaging
- ClinicalTrials.gov ID
- NCT03270865
- Acronym / sponsor ID
- Notal U-001 V. 1.0
- Conditions
- AMD Population - Intermediate or Advanced AMD, DR Population- With or Without Diabetic Macular Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Notal Vision Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 1 Sep 2017 (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 purpose of the study "Usability and Ergonomic Evaluation of Self-Positioning System for Retinal Imaging" is to enable self-operation of a monitoring device in home-simulated environment
Detailed description
One of the main challenges in developing a retinal imager is to design it to be self-operated by elderly patients in their home setting The study's objective is to explore ergonomic solutions that will allow the user to perform imaging on their own. The study will be done in a home-simulated environment using a dedicated ergonomic system (termed "PAF" - Positioning And Fixation system) that stimulates the retinal imager and enables to record the tested subject using standard cameras. The prototype doesn't include the retinal imager and does not include any imaging capabilities aside from standard means of photography Subjects will be evaluating for positioning accuracy and comfort by comparing different methods. Pupil position will be recorded using commercial off the shelf cameras when the subject is performing simple ergonomic tasks while looking at a screen presenting images.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usability and Ergonomic Evaluation of Self-Positioning System | Experimental | Device: PAF (Positioning And Fixation device) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≥ 65
- Able to understand and sign the informed consent form
- Ability to communicate verbally
- AMD (interim and advanced) or diabetic retinopathy (with and without DME)
Key exclusion criteria (1 listed)
- Visual acuity >=20/200 in the better eye
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 |
|---|---|---|
| PAF (Positioning And Fixation device)Up to 60 Subjects will be evaluating for positioning accuracy and comfort by comparing different methods utilizing the PAF device. Some methods of positioning will be applied and compare for each usability factor X, Y, Z location, and fixation. The patient will be evaluated before pupil dilation. VA and ophthalmic diagnoses will be recorded. Pupil position will be recorded using 3 commercial off the shelf cameras when the subject is performing simple ergonomic tasks while looking at a screen presenting images. Each testing session will be limited 20 min long. Subjects will be able to rest within the testing session if required. Total session time per patient will not exceed 30 minutes. | Device | Usability and Ergonomic Evaluation of Self-Positioning System |
Primary outcome
spatial location of the pupil, during an eye examination
Time frame: 1 year
documentation of pupil location by a camera
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 13 Jun 2019.
Related trials for AMD Population - Intermediate or Advanced AMD
Not yet recruitingObservational study
MIND-AMD Study: a Multidisciplinary Investigation of Neuroretinal Damage in Age-related Macular Degeneration.
Age-Related (Dry) Macular Degeneration, Age-Related Macular Degeneration (AMD)
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?
A study testing PAF (Positioning And Fixation device) in people with AMD Population - Intermediate or Advanced AMD and DR Population- With or Without Diabetic Macular Edema, run by Notal Vision Ltd. 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 4 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 13 Jun 2019. 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?
spatial location of the pupil, during an eye examination (time frame: 1 year). 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 13 Jun 2019.