Next Generation Cataract Surgery Study

Alcon

Status: Completed

Conditions: Cataract

Treatments: Device: UNITY VCS; Procedure: Anterior segment ophthalmic surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT06071104

CTV678-E002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 121 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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121 participants in 1 patient group

UNITY VCS

Experimental group

Description:

Anterior segment ophthalmic surgery performed with UNITY VCS

Treatment:

Procedure: Anterior segment ophthalmic surgery

Device: UNITY VCS