EFFECTIVENESS AND SAFETY ASSESSMENT OF THE VISTA VITRECTOMY PROBE (NCT07140692) | Clinical Trial Compass
CompletedNot Applicable
EFFECTIVENESS AND SAFETY ASSESSMENT OF THE VISTA VITRECTOMY PROBE
United States40 participantsStarted 2023-09-14
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Degree of change in iTrace Dysfunctional Lens Index (DLI) from baseline to post-operative visit Day 30
Timeframe: Day 30 (+/- 7 days)
2
Degree of change in Kim Floater Survey from baseline to post-operative visit Day 30
Timeframe: Day 30 (+/-7 days)
3
Degree of change in surgeon assessed vitreous opacities from baseline to post-operative visit Day 30