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 range18 Years

SexALL

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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.

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