N/A
Completed N=108
Next Generation Cataract Surgery Study
Source: ClinicalTrials.gov NCT06071104 ↗Enrolled (actual)
108
Serious AEs
1.5%
Results posted
Jun 2025
Primary outcomePrimary: Percent of 'Yes' Responses to the Binary Question: "Did UNITY VCS Anterior Segment Surgical Functionality Perform Per the Intended Use as Defined in Protocol Section 5.1?" — 99.1 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 user preference data.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of 'Yes' Responses to the Binary Question: "Did UNITY VCS Anterior Segment Surgical Functionality Perform Per the Intended Use as Defined in Protocol Section 5.1?" |
99.1 | — |
| SECONDARY Time From Incision Entry to Incision Closure |
376.8 | — |
Eligibility Criteria
Key Inclusion Criteria
- Able to understand and sign an IRB/IEC approved Informed Consent form.
- Willing and able to attend all scheduled visits as required by the protocol.
- Clinically documented diagnosis of age-related noncomplicated cataract.
- Eligible to undergo primary hydrophobic acrylic intraocular lens implantation into the capsular bag.
- Other protocol-defined inclusion criteria may apply.
Key Exclusion Criteria
- Women of childbearing potential as defined in the protocol.
- Planned postoperative procedures during the course of the study in the operative eye.
- Previous intraocular or corneal surgery in the operative eye.
- Diagnosis of glaucoma or ocular hypertension (IOP > 21 mmHg) in the operative eye.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT06071104). 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.