Next Generation Cataract Surgery Study

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Procedure: Anterior segment ophthalmic surgery; Device: UNITY VCS

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 Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92122
      • Gordon Schanzlin New Vision Institute, A TLC Laser Eye Center
    • Ventura, California, United States, 93003
      • Miramar Eye Specialists Medical Group
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Wolfe Eye Clinic
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Vance Thompson Vision

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UNITY VCS; Anterior segment ophthalmic surgery performed with UNITY VCS	Procedure: Anterior segment ophthalmic surgery; Cataract surgery during which the crystalline lens (often cloudy) is broken into small pieces and gently removed from the eye with suction (phacoemulsification); Device: UNITY VCS; UNITY Vitreoretinal Cataract System (VCS) with console, remote control, foot controller, UNITY Cataract FMS Pack, and UNITY Anterior Vitrectomy Kit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0 surgery

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Chair: Clinical Trial Lead, CRD Surgical, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2023
• Primary Completion (Actual): May 23, 2024
• Study Completion (Actual): June 28, 2024

Study Registration Dates

• First Submitted: October 2, 2023
• First Submitted That Met QC Criteria: October 2, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: May 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Anterior segment ophthalmic surgery
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CTV678-E002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes