Diabetic RetinopathyNCT05608265
Real-time Eye Tracking and Imaging of the Eye in Diabetic Retinopathy Patients
A study testing OSNAT 800 IO in people with Diabetic Retinopathy and Retinal Imaging, run by PulseMedica at 1 site in Canada.
Trial summary
Diabetic retinopathy (DR) is a leading cause of vision loss in working age Canadians. Current treatment consists of early detection and laser photocoagulation therapy for preventing progressive or severe vision loss. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Retinopathy, Retinal Imaging
- What is being tested?
- OSNAT 800 IO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 31 Aug 2022to 21 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 70 years of age
- Male or female
- Diagnosed diabetic retinopathy
- Two eyes with clear ocular media
Who cannot join
- Patients younger than 18 years and over 70 years of age
- Patients without diabetic retinopathy
- Opacification of cornea, lens, or vitreous
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scanning Laser Ophthalmoscopy Registered Optical Coherence Tomography for Real-Time Eye Tracking
Diabetic retinopathy (DR) is a leading cause of vision loss in working age Canadians. Current treatment consists of early detection and laser photocoagulation therapy for preventing progressive or severe vision loss. Microaneurysms (MA) are the earliest, clinically visible changes of DR, which are visualized using specialized imaging technologies. PulseMedica is developing a three-dimensional (3D) retinal imaging system with real-time eye tracking capabilities. The purpose of this study is to assess the feasibility of PulseMedica's prototype device, the OSNAT800 Imaging Only (IO), in providing real-time tracking of eye movements in patients with DR. It is hypothesized that the OSNAT 800 IO will be able to perform real-time eye tracking while imaging patients with DR.
- Conditions
- Diabetic Retinopathy, Retinal Imaging
- Being tested
- OSNAT 800 IO
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSNAT 800 IODevice
Real-time, combined scanning laser ophthalmoscope (SLO) and optical coherence tomography (OCT) for retinal imaging
| Study group | Role | What they receive |
|---|---|---|
| Retinal Imaging using the OSNAT800 IO device | Experimental | Patients will have their eyes imaged with the OSNAT800 IO device in addition to a routine standard of care appointment. Receives: Device: OSNAT 800 IO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful performance of the real-time eye tracking function by post-image processing
Successful acquisition of retinal images
Measured: Through study completion, an average of 6 months
Secondary outcomes (2)
Device usability as assessed by a survey
Qualitative assessment of user feedback
Measured: Through study completion, an average of 6 months
Image Quality as assessed by user assessment of image quality parameters
Qualitative assessment of image at time of acquisition
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start31 Aug 2022
- Primary completion21 Mar 2023
- Study completion21 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- PulseMedica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608265
- Sponsor's protocol ID
- OSNATFIHIO001
- Status last verified
- Jan 2024
- First submitted
- 26 Sep 2022
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scanning Laser Ophthalmoscopy Registered Optical Coherence Tomography for Real-Time Eye Tracking
- ClinicalTrials.gov ID
- NCT05608265
- Acronym / sponsor ID
- OSNATFIHIO001
- Conditions
- Diabetic Retinopathy, Retinal Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- PulseMedicaIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 21 Mar 2023 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 8 Nov 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.
Diabetic retinopathy (DR) is a leading cause of vision loss in working age Canadians. Current treatment consists of early detection and laser photocoagulation therapy for preventing progressive or severe vision loss. Microaneurysms (MA) are the earliest, clinically visible changes of DR, which are visualized using specialized imaging technologies. PulseMedica is developing a three-dimensional (3D) retinal imaging system with real-time eye tracking capabilities. The purpose of this study is to assess the feasibility of PulseMedica's prototype device, the OSNAT800 Imaging Only (IO), in providing real-time tracking of eye movements in patients with DR. It is hypothesized that the OSNAT 800 IO will be able to perform real-time eye tracking while imaging patients with DR.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retinal Imaging using the OSNAT800 IO device | Experimental | Device: OSNAT 800 IOPatients will have their eyes imaged with the OSNAT800 IO device in addition to a routine standard of care appointment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between 18 and 70 years of age
- Male or female
- Diagnosed diabetic retinopathy
- Two eyes with clear ocular media
Key exclusion criteria (3 listed)
- Patients younger than 18 years and over 70 years of age
- Patients without diabetic retinopathy
- Opacification of cornea, lens, or vitreous
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 |
|---|---|---|
| OSNAT 800 IOReal-time, combined scanning laser ophthalmoscope (SLO) and optical coherence tomography (OCT) for retinal imaging | Device | Retinal Imaging using the OSNAT800 IO device |
Primary outcome
Successful performance of the real-time eye tracking function by post-image processing
Time frame: Through study completion, an average of 6 months
Successful acquisition of retinal images
2 secondary outcomes
Device usability as assessed by a survey
Time frame: Through study completion, an average of 6 months
Image Quality as assessed by user assessment of image quality parameters
Time frame: Through study completion, an average of 6 months
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 25 Jan 2024.
- Individual participant dataSharing planned: No
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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?
A study testing OSNAT 800 IO in people with Diabetic Retinopathy and Retinal Imaging, run by PulseMedica at 1 site in Canada.
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 3 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 25 Jan 2024. 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 Canada. 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?
Successful performance of the real-time eye tracking function by post-image processing (time frame: Through study completion, an average of 6 months). 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 25 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.