Next Generation Cataract Surgery Study

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Procedure: Anterior segment ophthalmic surgery; Device: UNITY VCS

• Registration Number: NCT06071104
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to obtain device-specific safety and performance clinical data to support marketability in Europe.

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.

Study Timeline

• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-02
• Study First Posted: 2023-10-06
• Study Start: 2023-12-06
• Primary Completion: 2024-05-23
• Study Completion: 2024-06-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
UNITY VCS	Anterior segment ophthalmic surgery	Anterior segment ophthalmic surgery performed with UNITY VCS
UNITY VCS	UNITY VCS	Anterior segment ophthalmic surgery performed with UNITY VCS

Primary Outcome Measures

Name	Time	Method
Percent of 'yes' responses to the question: Did UNITY VCS using anterior segment surgical functionality perform per the intended use as defined in Protocol Section 5.1?	Day 0 surgery	The investigator will answer the question, 'Did UNITY VCS using anterior segment surgical functionality perform per the intended use?" with "yes" or "no."

Secondary Outcome Measures

Name	Time	Method
Time from incision entry to incision closure	Day 0 surgery	Time from incision entry to incision closure will be measured using a stopwatch and recorded in seconds.

Trial Locations

Locations (4)

Miramar Eye Specialists Medical Group; 🇺🇸 Ventura, California, United States

Wolfe Eye Clinic; 🇺🇸 West Des Moines, Iowa, United States

Vance Thompson Vision; 🇺🇸 Sioux Falls, South Dakota, United States

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