Next Generation Cataract Surgery Study

NCT06071104 | Completed Results FDA Device

• 1 other identifier: CTV678-E002
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 4

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.

Conditions

Cataract

Keywords

Anterior segment ophthalmic surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time From Incision Entry to Incision Closure

  Day 0 surgery

Study Arms (1)

UNITY VCS

EXPERIMENTAL

Anterior segment ophthalmic surgery performed with UNITY VCS

Procedure: Anterior segment ophthalmic surgery; Device: UNITY VCS

Interventions

Anterior segment ophthalmic surgery PROCEDURE

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

UNITY VCS

UNITY VCS DEVICE

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

UNITY VCS

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (4)

Gordon Schanzlin New Vision Institute, A TLC Laser Eye Center

San Diego, California, 92122, United States

Location

Miramar Eye Specialists Medical Group

Ventura, California, 93003, United States

Location

Wolfe Eye Clinic

West Des Moines, Iowa, 50266, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Sr. Principal Clinical Project Lead, Surgical
• Organization: Alcon Research LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Trial Lead, CRD Surgical

  Alcon Research, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 6, 2023
• Study Start: December 6, 2023
• Primary Completion: May 23, 2024
• Study Completion: June 28, 2024
• Last Updated: June 4, 2025
• Results First Posted: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)