Vitreous FloatersNCT07140692
EFFECTIVENESS AND SAFETY ASSESSMENT OF THE VISTA VITRECTOMY PROBE
A study testing Vitrectomy in people with Vitreous Floaters and Vitreous Opacities, run by The Eye Centers of Racine and Kenosha at 1 site in United States.
Trial summary
Vitreous opacities or floaters are a common ocular condition that can cause significant impairment in vision-related quality of life (QoL) in some patients. Vitrectomy involves the surgical removal of vitreous humour, the transparent jelly, from inside the eye that contains vitreous opacities and floaters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitreous Floaters, Vitreous Opacities
- What is being tested?
- Vitrectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2023to 1 Jul 2024
- 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
- Male or female participant with age ≥ 18 years at the time of screening.
- Subjects with Posterior chamber Intraocular lens (PCIOL) in one or both the eyes (both eyes will be independently assessed).
- Subjects must be able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study.
- Subjects must be willing and able to comply with all treatment and follow-up study procedures.
- Complaints of decreased vision/decreased quality of vision due to vitreous floaters which is having an impact on Activities of daily living (ADLs).
- Documentation of vitreous opacities on Slit lamp exam/Dilated Fundus Exam (SLE/DFE).
- Documentation of decreased DLI on iTrace.
Who cannot join
- Subjects with history of retinal tear/detachment, macular edema, Epi-retinal membrane (ERM), vitreomacular traction syndrome (VMT), Age-related macular degeneration (AMD), Proliferative Diabetic Retinopathy (PDR), or other significant retinal disorders in procedural eye.
- Subjects with History of trauma to operative eye.
- Subjects with bleeding disorders or anticoagulation.
- Subjects with history of ocular herpetic infections.
- Female subjects of child bearing potential with positive urine pregnancy test.
- Subjects who have participated in any drug or device clinical investigation within 30 days prior to entry into or during this study.
- Any medical condition that would be contraindicated for cataract surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Eye Centers of Racine & Kenosha
Kenosha, Wisconsin, 53142
About this study
Official title: VISTA OPHTHALMICS 1-STEP VITRECTOR POST MARKET LIMITED VITREOUS REMOVAL (LVR) CLINICAL ASSESSMENT
Vitreous opacities or floaters are a common ocular condition that can cause significant impairment in vision-related quality of life (QoL) in some patients. Vitrectomy involves the surgical removal of vitreous humour, the transparent jelly, from inside the eye that contains vitreous opacities and floaters. The present post-market clinical assessment study aims to assess the safety and effectiveness performance of the Vista 1-Step vitrectomy probe in adult pseudophakic patients with visually symptomatic opacities.
Read the detailed description
Vitreous opacities or floaters are a common ocular condition that seems ubiquitous in a retina practice. Although symptoms are minimal in most patients, they can cause significant impairment in vision-related quality of life (QoL) in some patients.
Vitrectomy is a surgical procedure to remove the vitreous humour, the transparent jelly, from inside the eye. Vitrectomy Surgery can be of two types: Full and Limited. Full Vitrectomy is the commonly used and standard technique for repairing retinal detachments, removing membranes or haemorrhages, and involves vitreous detachment from the retina and its removal, both centrally and peripherally. Limited Vitrectomy is a new technique which focuses on the removal of only the central part of the vitreous or Core with the Vitreous Opacities or "Floaters" in it, and without intentionally detaching it from the retina.
The Vista Ophthalmics vitrectomy probe is a single-use vitrector intended to perform anterior/posterior vitrectomy procedures and to remove vitreous and dissect tissue in the eye. The Vista Ophthalmic's probe is designed as a stand-alone handpiece for use with ophthalmic systems.
- Conditions
- Vitreous Floaters, Vitreous Opacities
- Being tested
- Vitrectomy
- Keywords
- Vitrectomy, Vista 1-Step Vitrector, Vitreous opacities or floaters
- Medical subject headings
- vitreous floaters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitrectomyDevice
In this single-arm, non-comparative study, patients presenting with vitreous opacities affecting daily activities of living will undergo vitrectomy using the single-use vitrector probe of Vista Ophthalmics for the removal of the vitreous opacities.
| Study group | Role | What they receive |
|---|---|---|
| Vista Ophthalmics vitrectomy | Experimental | In this single-arm, non-comparative study, patients presenting with vitreous opacities affecting daily activities of living will undergo vitrectomy using the single-use vitrector probe of Vista Ophthalmics for the removal of the vitreous opacities. Receives: Device: Vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of change in iTrace Dysfunctional Lens Index (DLI) from baseline to post-operative visit Day 30
iTrace Dysfunctional Lens Index (DLI) score
Measured: Day 30 (+/- 7 days)
Degree of change in Kim Floater Survey from baseline to post-operative visit Day 30
Assessment using Kim Floater Questionnaire
Measured: Day 30 (+/-7 days)
Degree of change in surgeon assessed vitreous opacities from baseline to post-operative visit Day 30
Dilated Fundus/Peripheral Exam
Measured: Day 30 (+/-7 days)
Secondary outcomes (1)
Incidence of post-operative adverse events
Ophthalmic examination
Measured: Day 30 (+/- 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2025
- Study start14 Sep 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitreous 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The Vista Ophthalmics 1-Step Vitrector is intended to perform anterior/posterior vitrectomy procedures and remove vitreous and dissected tissue in the eye. It consists of a single-use vitrector with air supply tubing.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Eye Centers of Racine and Kenosha
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inder Paul Singh, M.D., The Eye Centers of Racine and Kenosha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140692
- Sponsor's protocol ID
- ECRK-LVR-01
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 25 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VISTA OPHTHALMICS 1-STEP VITRECTOR POST MARKET LIMITED VITREOUS REMOVAL (LVR) CLINICAL ASSESSMENT
- ClinicalTrials.gov ID
- NCT07140692
- Acronym / sponsor ID
- ECRK-LVR-01
- Conditions
- Vitreous Floaters, Vitreous Opacities
- Keywords
- Vitrectomy, Vista 1-Step Vitrector, Vitreous opacities or floaters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Eye Centers of Racine and KenoshaUniversity, hospital or other
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 25 Aug 2025 (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 or floaters are a common ocular condition that can cause significant impairment in vision-related quality of life (QoL) in some patients. Vitrectomy involves the surgical removal of vitreous humour, the transparent jelly, from inside the eye that contains vitreous opacities and floaters. The present post-market clinical assessment study aims to assess the safety and effectiveness performance of the Vista 1-Step vitrectomy probe in adult pseudophakic patients with visually symptomatic opacities.
Detailed description
Vitreous opacities or floaters are a common ocular condition that seems ubiquitous in a retina practice. Although symptoms are minimal in most patients, they can cause significant impairment in vision-related quality of life (QoL) in some patients.
Vitrectomy is a surgical procedure to remove the vitreous humour, the transparent jelly, from inside the eye. Vitrectomy Surgery can be of two types: Full and Limited. Full Vitrectomy is the commonly used and standard technique for repairing retinal detachments, removing membranes or haemorrhages, and involves vitreous detachment from the retina and its removal, both centrally and peripherally. Limited Vitrectomy is a new technique which focuses on the removal of only the central part of the vitreous or Core with the Vitreous Opacities or "Floaters" in it, and without intentionally detaching it from the retina.
The Vista Ophthalmics vitrectomy probe is a single-use vitrector intended to perform anterior/posterior vitrectomy procedures and to remove vitreous and dissect tissue in the eye. The Vista Ophthalmic's probe is designed as a stand-alone handpiece for use with ophthalmic systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The Vista Ophthalmics 1-Step Vitrector is intended to perform anterior/posterior vitrectomy procedures and remove vitreous and dissected tissue in the eye. It consists of a single-use vitrector with air supply tubing.
| Arm | Type | Receives |
|---|---|---|
| Vista Ophthalmics vitrectomy | Experimental | Device: VitrectomyIn this single-arm, non-comparative study, patients presenting with vitreous opacities affecting daily activities of living will undergo vitrectomy using the single-use vitrector probe of Vista Ophthalmics for the removal of the vitreous opacities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female participant with age ≥ 18 years at the time of screening.
- Subjects with Posterior chamber Intraocular lens (PCIOL) in one or both the eyes (both eyes will be independently assessed).
- Subjects must be able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study.
- Subjects must be willing and able to comply with all treatment and follow-up study procedures.
- Complaints of decreased vision/decreased quality of vision due to vitreous floaters which is having an impact on Activities of daily living (ADLs).
Key exclusion criteria (7 listed)
- Subjects with history of retinal tear/detachment, macular edema, Epi-retinal membrane (ERM), vitreomacular traction syndrome (VMT), Age-related macular degeneration (AMD), Proliferative Diabetic Retinopathy (PDR), or other significant retinal disorders in procedural eye.
- Subjects with History of trauma to operative eye.
- Subjects with bleeding disorders or anticoagulation.
- Subjects with history of ocular herpetic infections.
- Female subjects of child bearing potential with positive urine pregnancy test.
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 |
|---|---|---|
| VitrectomyIn this single-arm, non-comparative study, patients presenting with vitreous opacities affecting daily activities of living will undergo vitrectomy using the single-use vitrector probe of Vista Ophthalmics for the removal of the vitreous opacities. | Device | Vista Ophthalmics vitrectomy |
Primary outcome
Degree of change in iTrace Dysfunctional Lens Index (DLI) from baseline to post-operative visit Day 30
Time frame: Day 30 (+/- 7 days)
iTrace Dysfunctional Lens Index (DLI) score
Degree of change in Kim Floater Survey from baseline to post-operative visit Day 30
Time frame: Day 30 (+/-7 days)
Assessment using Kim Floater Questionnaire
Degree of change in surgeon assessed vitreous opacities from baseline to post-operative visit Day 30
Time frame: Day 30 (+/-7 days)
Dilated Fundus/Peripheral Exam
1 secondary outcome
Incidence of post-operative adverse events
Time frame: Day 30 (+/- 7 days)
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 Aug 2025.
- 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 Vitrectomy in people with Vitreous Floaters and Vitreous Opacities, run by The Eye Centers of Racine and Kenosha at 1 site in United States.
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 7 inclusion and 7 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 Aug 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 United States. 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?
Degree of change in iTrace Dysfunctional Lens Index (DLI) from baseline to post-operative visit Day 30 (time frame: Day 30 (+/- 7 days)). The study lists 3 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 25 Aug 2025.