FloatersNCT06097897
Imaging of Vitreous Opacities in Human Eyes
A study testing SVO-ID in people with Floaters and Vitreous Opacities, run by PulseMedica at 1 site in Panama.
Trial summary
Vitreous opacities (VOs), commonly known as floaters, are dark spots that appear in, and may float across your vision. Presently, there is a lack of available data in the literature regarding VOs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Floaters, Vitreous Opacities
- What is being tested?
- SVO-ID
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 sitePanama
- Study dates
- 1 Apr 2024to 18 Mar 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- SVO-related symptoms in vision
- Clear ocular media, to allow a clear view of the vitreous for the SVO-ID
Who cannot join
- Presence of vitreous hemorrhage
- Cataract Grade 3 and above
- Opacification of lens, cornea, or vitreous
- Diagnosis of narrow-angle glaucoma
- Refractive error is outside the range of -6D to +3D
- Astigmatism is outside the range of +/- 2D of cylinder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Non-Invasive Imaging Device for the Acquisition of Imaging Data of Vitreous Opacities in Human Eyes
Vitreous opacities (VOs), commonly known as floaters, are dark spots that appear in, and may float across your vision. Presently, there is a lack of available data in the literature regarding VOs. This study aims to obtain imaging data of VOs in the population to build an imaging database of VOs to learn more about them.
- Conditions
- Floaters, Vitreous Opacities
- Being tested
- SVO-ID
- Medical subject headings
- vitreous floaters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SVO-IDDevice
Combined scanning laser ophthalmoscope (SLO) and optical coherence tomography (OCT) for imaging of the eye
| Study group | Role | What they receive |
|---|---|---|
| Imaging using the SVO-ID | Experimental | Patients will have their eyes imaged with the SVO-ID as part of a study visit. Receives: Device: SVO-ID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful capture of SLO and OCT imaging data of SVOs for algorithm development
Successful collection of SLO and OCT imaging data
Measured: Through study completion, an average of one year
Secondary outcomes (1)
Collection of patient-reported symptoms
Patient feedback regarding symptoms related to SVOs being imaged
Measured: Through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start1 Apr 2024
- Primary completion18 Mar 2025
- Study completion18 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FloatersStudies 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
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- PulseMedica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097897
- Sponsor's protocol ID
- SVO-IDFIH001
- Status last verified
- Apr 2025
- First submitted
- 26 Sep 2023
- Last updated
- 8 Apr 2025
- 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 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Non-Invasive Imaging Device for the Acquisition of Imaging Data of Vitreous Opacities in Human Eyes
- ClinicalTrials.gov ID
- NCT06097897
- Acronym / sponsor ID
- SVO-IDFIH001
- Conditions
- Floaters, Vitreous Opacities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- PulseMedicaIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 18 Mar 2025 (actual)
- First posted
- 24 Oct 2023 (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.
Vitreous opacities (VOs), commonly known as floaters, are dark spots that appear in, and may float across your vision. Presently, there is a lack of available data in the literature regarding VOs. This study aims to obtain imaging data of VOs in the population to build an imaging database of VOs to learn more about them.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging using the SVO-ID | Experimental | Device: SVO-IDPatients will have their eyes imaged with the SVO-ID as part of a study visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or older
- SVO-related symptoms in vision
- Clear ocular media, to allow a clear view of the vitreous for the SVO-ID
Key exclusion criteria (6 listed)
- Presence of vitreous hemorrhage
- Cataract Grade 3 and above
- Opacification of lens, cornea, or vitreous
- Diagnosis of narrow-angle glaucoma
- Refractive error is outside the range of -6D to +3D
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 |
|---|---|---|
| SVO-IDCombined scanning laser ophthalmoscope (SLO) and optical coherence tomography (OCT) for imaging of the eye | Device | Imaging using the SVO-ID |
Primary outcome
Successful capture of SLO and OCT imaging data of SVOs for algorithm development
Time frame: Through study completion, an average of one year
Successful collection of SLO and OCT imaging data
1 secondary outcome
Collection of patient-reported symptoms
Time frame: Through study completion, an average of one year
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 8 Apr 2025.
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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 SVO-ID in people with Floaters and Vitreous Opacities, run by PulseMedica at 1 site in Panama.
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 3 inclusion and 6 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 8 Apr 2025. 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 Panama. 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 capture of SLO and OCT imaging data of SVOs for algorithm development (time frame: Through study completion, an average of one 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 8 Apr 2025.