Next Generation Cataract and Vitreoretinal Surgery Study
- Conditions
- Vitreoretinal Disease With or Without Cataracts
- Registration Number
- NCT06165744
- Lead Sponsor
- Alcon Research
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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?" 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 Outcome Measures
Name Time Method Mean Total Time in Eye Day 0 operative, up to surgery completion The time from first entry into eye/first trocar in to incision closure/last trocar out was measured using a stopwatch and recorded in minutes. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.
Percent of 'Yes' Responses to the Binary Question, "Was Anatomical Success Achieved for Intended Treatment?" Month 3 Postoperative As reported by the examiner at the Month 3 visit. Intended treatment included macular hole closure, retinal attachment, etc. as applicable for the patient's condition. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.
Mean Change in Monocular Best Corrected Distance Visual Acuity (BCDVA) From Preoperative to Month 3 Preoperative (Day -30 to 0), Month 3 Postoperative Visual acuity was assessed with refractive correction in place using a Snellen visual acuity chart. Results were converted to decimal VA, where 2.00 decimal equates to 20/16 Snellen (better than normal distance eyesight), 1.00 decimal equates to 20/20 Snellen (normal distance eyesight), and 0.1 decimal equates to 6/600 Snellen (worse than normal distance eyesight). A positive change value indicates an improvement. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.
Trial Locations
- Locations (5)
NSW Retina Pty Ltd
🇦🇺Hurstville, New South Wales, Australia
Southwest Retina
🇦🇺Liverpool, New South Wales, Australia
Sydney Retina Clinic & Day Surgery
🇦🇺Sydney, New South Wales, Australia
Adelaide Eye & Retina Centre
🇦🇺Adelaide, South Australia, Australia
Pennington Eye Clinic
🇦🇺North Adelaide, South Australia, Australia
NSW Retina Pty Ltd🇦🇺Hurstville, New South Wales, Australia