Next Generation Cataract Surgery Study
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 121
- Locations
- 4
- Primary Endpoint
- 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?"
Overview
Brief 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.
Detailed Description
Subjects will attend a screening visit (Day -60 to Day 0), a surgery visit (Day 0), and 3 post-surgical visits (Day 1, Week 1, Month 1) for an overall individual duration of up to 3 months. One eye (study eye) will be treated. This study will be conducted in the United States.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
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.
Outcomes
Primary Outcomes
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?"
Time Frame: Day 0
As recorded by the surgeon on a user questionnaire based on Day 0 surgery experience. From Protocol Section 5.1, the intended use for UNITY VCS is to facilitate management of fluid as well as removal, cutting, and coagulation of ocular materials. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.
Secondary Outcomes
- Time From Incision Entry to Incision Closure(Day 0 surgery)