N/A
Completed N=118
Next Generation Cataract and Vitreoretinal Surgery Study
Vitreoretinal Disease With or Without Cataracts
Source: ClinicalTrials.gov NCT06165744 ↗
Enrolled (actual)
118
Serious AEs
12.7%
Results posted
Jun 2025
Primary outcomePrimary: 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?" — 100 percentage of responses
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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?" |
100 | — |
| SECONDARY Mean Total Time in Eye |
22.788 | — |
| SECONDARY Percent of 'Yes' Responses to the Binary Question, "Was Anatomical Success Achieved for Intended Treatment?" |
96.6 | — |
| SECONDARY Mean Change in Monocular Best Corrected Distance Visual Acuity (BCDVA) From Preoperative to Month 3 |
0.186 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06165744). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.