Next Generation Cataract Surgery Study
- Conditions
- Cataract
- Registration Number
- NCT06071104
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
- 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
- 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.
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 Anterior Segment 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 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 Outcome Measures
Name Time Method Time From Incision Entry to Incision Closure Day 0 surgery The time from incision entry to incision closure was measured using a stopwatch and recorded in seconds. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.
Trial Locations
- Locations (4)
Gordon Schanzlin New Vision Institute, A TLC Laser Eye Center
🇺🇸San Diego, California, United States
Miramar Eye Specialists Medical Group
🇺🇸Ventura, California, United States
Wolfe Eye Clinic
🇺🇸West Des Moines, Iowa, United States
Vance Thompson Vision
🇺🇸Sioux Falls, South Dakota, United States
Gordon Schanzlin New Vision Institute, A TLC Laser Eye Center🇺🇸San Diego, California, United States