Next Generation Cataract and Vitreoretinal Surgery Study

NCT ID: NCT06165744

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-27
• Study Completion Date: 2024-08-19

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 formal user feedback.

Detailed Description

Subjects will attend a screening visit (Day -30 to Day 0), a surgery visit (Day 0), and 4 post-surgical visits (Day 1, Week 1, Month 1, Month 3) for an overall individual duration of approximately 4 months. One eye (study eye) will be treated. This study will be conducted in Australia.

Conditions

Vitreoretinal Disease With or Without Cataracts

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UNITY VCS

Posterior segment surgery in the operating room with or without simultaneous cataract surgery performed with UNITY VCS

Group Type: EXPERIMENTAL

UNITY Vitreoretinal Cataract System

Intervention Type: DEVICE

UNITY Vitreoretinal Cataract System (VCS) with console, remote control, foot controller, UNITY TOTAL PLUS Combined Procedure Pak, and additional devices as needed to complete surgery

Posterior segment surgery in the operating room with or without simultaneous cataract surgery

Intervention Type: PROCEDURE

Posterior segment surgery involves removal of the vitreous (i.e., vitrectomy) followed by additional interventions as needed. Cataract surgery involves removal of the crystalline lens (which is often cloudy).

Interventions

UNITY Vitreoretinal Cataract System

UNITY Vitreoretinal Cataract System (VCS) with console, remote control, foot controller, UNITY TOTAL PLUS Combined Procedure Pak, and additional devices as needed to complete surgery

Intervention Type: DEVICE

Posterior segment surgery in the operating room with or without simultaneous cataract surgery

Posterior segment surgery involves removal of the vitreous (i.e., vitrectomy) followed by additional interventions as needed. Cataract surgery involves removal of the crystalline lens (which is often cloudy).

Intervention Type: PROCEDURE

Other Intervention Names

UNITY VCS

Eligibility Criteria

Inclusion Criteria

• Requires posterior segment surgery in the operating room with or without simultaneous cataract surgery;
• Clear media except for cataract and vitreous hemorrhage;
• In simultaneous cataract and vitreoretinal surgery, eligible to undergo primary hydrophobic acrylic intraocular lens (IOL) implantation into the capsular bag;

Exclusion Criteria

• Previous vitrectomy in the operative eye aside from those requiring silicone oil removal;
• Neovascular or uncontrolled glaucoma;
• Planned glaucoma or postoperative surgeries during study aside from silicone oil removal;
• Inadequate pupil dilation (less than 6 millimeters);

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sr. Clinical Operations Lead, Surgical

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

NSW Retina Pty Ltd

Hurstville, New South Wales, Australia

Southwest Retina

Liverpool, New South Wales, Australia

Sydney Retina Clinic & Day Surgery

Sydney, New South Wales, Australia

Adelaide Eye & Retina Centre

Adelaide, South Australia, Australia

Pennington Eye Clinic

North Adelaide, South Australia, Australia

Countries

Australia

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CTV678-E001

Identifier Type: -

Identifier Source: org_study_id