CompletedNot Applicable

Next Generation Cataract and Vitreoretinal Surgery Study

Australia120 participantsStarted 2024-02-27

Plain-language summary

The purpose of this study is to obtain device-specific safety and performance clinical data to support marketability in Europe and to collect formal user feedback.

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.

Key Inclusion Criteria: * Requires posterior segment surgery in the operating room with or without simultaneous cataract surgery; * Clear media except for cataract and vitreous hemorrhage; * In simultaneous cataract and vitreoretinal surgery, eligible to undergo primary hydrophobic acrylic intraocular lens (IOL) implantation into the capsular bag; * Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: * Previous vitrectomy in the operative eye aside from those requiring silicone oil removal; * Neovascular or uncontrolled glaucoma; * Planned glaucoma or postoperative surgeries during study aside from silicone oil removal; * Inadequate pupil dilation (less than 6 millimeters); * Other protocol-defined exclusion criteria may apply.

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

Percent of 'Yes' Responses to the Binary Question: "Did UNITY VCS Using Vitreoretinal or Combined Surgical Functionality Perform Per the Intended Use as Defined in Protocol Section 5.1?"

Timeframe: Day 0

Trial details

NCT IDNCT06165744

SponsorAlcon Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-23

Results submitted2025-05-16

View on ClinicalTrials.gov More Vitreoretinal Disease With or Without Cataracts trials

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.