VitrectomyNCT05689333
A Study to Evaluate the Safety and Performance of the Vista Probe for Vitrectomy Surgery
A study testing Vista Vitrectomy Probe in people with Vitrectomy, run by VISTA Ophthalmics at 4 sites in United States.
Trial summary
This is a prospective, single-arm, non-comparative, open-label, monocular, post approval study to assess safety and device performance of the Vista Vitrectomy Probe during vitrectomy surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitrectomy
- What is being tested?
- Vista Vitrectomy Probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesUnited States
- Study dates
- 9 Dec 2022to 7 May 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.
- Subject must have a clinical indication for anterior vitrectomy.
- 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.
Who cannot join
- Subjects who have experienced any significant trauma in the operative eye within the past month.
- Subjects with any active ocular infection or history of any herpetic infection that has cleared less than one month prior to the pre-operative visit.
- Subjects with prior history of uncontrolled glaucoma or uveitis refractory to treatment or ocular hypertension (IOP>30mm Hg) in study eye.
- Subjects with any medical condition (e.g., uncontrolled diabetes) that, based on the Investigator's medical judgment, poses a concern for the subjects' safety.
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
CBCC Global Research Site:001
Bala-Cynwyd, Pennsylvania, 19004
CBCC Global Research Site:002
Bradenton, Florida, 34209
CBCC Global Research Site:003
Los Angeles, California, 90067
CBCC Global Research Site:004
McAllen, Texas, 78503
About this study
Official title: A Prospective, Single-arm, Non-comparative, Open-label, Monocular, Post Approval Study to Assess Safety and Device Performance of the Vista Vitrectomy Probe During Vitrectomy Surgery
This is a prospective, single-arm, non-comparative, open-label, monocular, post approval study to assess safety and device performance of the Vista Vitrectomy Probe during vitrectomy surgery.
- Conditions
- Vitrectomy
- Being tested
- Vista Vitrectomy Probe
- Keywords
- Vitrectomy Probe, Vitreous aspiration & cutting, Dissect tissue in the eye
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vista Vitrectomy ProbeDevice
Vitrectomy will be performed through 27 GA Vista Ophthalmics vitrector
| Study group | Role | What they receive |
|---|---|---|
| 27 GA Vista Ophthalmics vitrector | Experimental | The vitrectomy will be performed through the pars plana using the 27 GA Vista Ophthalmics vitrector. Receives: Device: Vista Vitrectomy Probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-operative rates of retinal tears
Calculate the incidence of post-operative rates of retinal tears
Measured: Month 1
Incidence of retinal detachment
Calculate the incidence of post-operative retinal detachment
Measured: Month 1
Incidence of sclerotomy complications like leakage
Calculate the incidence of post-operative sclerotomy complications like leakage
Measured: Month 1
Incidence of ocular hypotony
Calculate the incidence of post-operative ocular hypotony
Measured: Month 1
Incidence of choroidal detachment
Calculate the incidence of post-operative choroidal detachment
Measured: Month 1
Incidence of visually significant vitreous hemorrhage
Calculate the incidence of post-operative visually significant vitreous hemorrhage (visual acuity defined by counting fingers or worse)
Measured: Month 1
Incidence of endophthalmitis
Calculate the incidence of post-operative endophthalmitis
Measured: Month 1
Secondary outcomes (2)
Surgeon- will assess device adequacy for removal of vitreous
Surgeon-assess device adequacy for removal of vitreous will be summarized using counts and percentages
Measured: Day 0 (Operative Visit)
Percentage of eyes with clinical evidence of incomplete vitrectomy, such as vitreous strands or pupil peaking
Percentage of eyes with clinical evidence of incomplete vitrectomy, such as vitreous strands or pupil peaking, at any post-operative visit will be summarized using counts and percentages
Measured: Days1, 7, 30 & 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start9 Dec 2022
- Primary completion7 May 2024
- Study completion7 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitrectomyStudies 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
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- VISTA Ophthalmics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CBCC Global Research
- Responsible party
- Sponsor
- Investigators
- Don Knowles, Study chair, VISTA Ophthalmics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689333
- Sponsor's protocol ID
- CBCC/2022/009
- Status last verified
- Mar 2025
- First submitted
- 22 Dec 2022
- Last updated
- 1 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Non-comparative, Open-label, Monocular, Post Approval Study to Assess Safety and Device Performance of the Vista Vitrectomy Probe During Vitrectomy Surgery
- ClinicalTrials.gov ID
- NCT05689333
- Acronym / sponsor ID
- CBCC/2022/009
- Conditions
- Vitrectomy
- Keywords
- Vitrectomy Probe, Vitreous aspiration & cutting, Dissect tissue in the eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- VISTA OphthalmicsIndustry (pharma, biotech, devices)
- Collaborators
- CBCC Global Research
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 19 Jan 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.
This is a prospective, single-arm, non-comparative, open-label, monocular, post approval study to assess safety and device performance of the Vista Vitrectomy Probe during vitrectomy surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 27 GA Vista Ophthalmics vitrector | Experimental | Device: Vista Vitrectomy ProbeThe vitrectomy will be performed through the pars plana using the 27 GA Vista Ophthalmics vitrector. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female participant with age ≥ 18 years at the time of screening.
- Subject must have a clinical indication for anterior vitrectomy.
- 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.
Key exclusion criteria (6 listed)
- Subjects who have experienced any significant trauma in the operative eye within the past month.
- Subjects with any active ocular infection or history of any herpetic infection that has cleared less than one month prior to the pre-operative visit.
- Subjects with prior history of uncontrolled glaucoma or uveitis refractory to treatment or ocular hypertension (IOP>30mm Hg) in study eye.
- Subjects with any medical condition (e.g., uncontrolled diabetes) that, based on the Investigator's medical judgment, poses a concern for the subjects' safety.
- 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 |
|---|---|---|
| Vista Vitrectomy ProbeVitrectomy will be performed through 27 GA Vista Ophthalmics vitrector | Device | 27 GA Vista Ophthalmics vitrector |
Primary outcome
Incidence of post-operative rates of retinal tears
Time frame: Month 1
Calculate the incidence of post-operative rates of retinal tears
Incidence of retinal detachment
Time frame: Month 1
Calculate the incidence of post-operative retinal detachment
Incidence of sclerotomy complications like leakage
Time frame: Month 1
Calculate the incidence of post-operative sclerotomy complications like leakage
Incidence of ocular hypotony
Time frame: Month 1
Calculate the incidence of post-operative ocular hypotony
Incidence of choroidal detachment
Time frame: Month 1
Calculate the incidence of post-operative choroidal detachment
Incidence of visually significant vitreous hemorrhage
Time frame: Month 1
Calculate the incidence of post-operative visually significant vitreous hemorrhage (visual acuity defined by counting fingers or worse)
Incidence of endophthalmitis
Time frame: Month 1
Calculate the incidence of post-operative endophthalmitis
2 secondary outcomes
Surgeon- will assess device adequacy for removal of vitreous
Time frame: Day 0 (Operative Visit)
Percentage of eyes with clinical evidence of incomplete vitrectomy, such as vitreous strands or pupil peaking
Time frame: Days1, 7, 30 & 90
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 1 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.
Don Knowles study chair
VISTA Ophthalmics
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vista Vitrectomy Probe in people with Vitrectomy, run by VISTA Ophthalmics at 4 sites 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 4 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 1 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 4 sites 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?
Incidence of post-operative rates of retinal tears (time frame: Month 1). 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 1 Apr 2025.