Next Generation Cataract and Vitreoretinal Surgery Study
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 120
- Locations
- 5
- Primary Endpoint
- 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?"
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 formal user feedback.
Detailed Description
Subjects will attend a screening visit (Day -30 to Day 0), a surgery visit (Day 0), and 4 post-surgical visits (Day 1, Week 1, Month 1, Month 3) for an overall individual duration of approximately 4 months. One eye (study eye) will be treated. This study will be conducted in Australia.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
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.
Outcomes
Primary Outcomes
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?"
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 the management of fluid and gases, as well as removal, grasping, cutting, illumination, and coagulation of ocular materials during ocular surgery. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.
Secondary Outcomes
- Mean Total Time in Eye(Day 0 operative, up to surgery completion)
- Percent of 'Yes' Responses to the Binary Question, "Was Anatomical Success Achieved for Intended Treatment?"(Month 3 Postoperative)
- Mean Change in Monocular Best Corrected Distance Visual Acuity (BCDVA) From Preoperative to Month 3(Preoperative (Day -30 to 0), Month 3 Postoperative)