Next Generation Cataract Surgery Study

Alcon Research121 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

121

Conditions

Cataract

Interventions

Anterior segment ophthalmic surgeryPROCEDURE

Cataract surgery during which the crystalline lens (often cloudy) is broken into small pieces and gently removed from the eye with suction (phacoemulsification)

UNITY VCSDEVICE

UNITY Vitreoretinal Cataract System (VCS) with console, remote control, foot controller, UNITY Cataract FMS Pack, and UNITY Anterior Vitrectomy Kit

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

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

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?"

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.

Time frame: Day 0

Secondary Outcomes

Time From Incision Entry to Incision Closure

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.

Time frame: Day 0 surgery

Data from ClinicalTrials.gov

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