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OpenTrials
Completed

NCT Number: NCT06071104

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gordon Schanzlin New Vision Institute, A TLC Laser Eye Center, San Diego, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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

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?"

    Time frame: 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 outcomes

  1. Time From Incision Entry to Incision Closure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 6, 2023
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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