Next Generation Cataract Surgery Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-06

Study Completion Date

2024-06-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cataract

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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UNITY VCS

Anterior segment ophthalmic surgery performed with UNITY VCS

Group Type EXPERIMENTAL

Anterior segment ophthalmic surgery

Intervention Type 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

Intervention Type DEVICE

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

Interventions

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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)

Intervention Type PROCEDURE

UNITY VCS

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

Intervention Type DEVICE

Eligibility Criteria

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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.

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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No