Next Generation Cataract and Vitreoretinal Surgery Study

NCT06165744 | Completed Results FDA Device

• 1 other identifier: CTV678-E001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

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.

Conditions

Vitreoretinal Disease With or Without Cataracts

Keywords

Vitreoretinal surgery; Vitreoretinal with cataract surgery

Outcome Measures

Primary Outcomes (1)

• Percent of 'Yes' Responses to the Binary Question: "Did UNITY VCS Using Vitreoretinal or Combined Surgical Functionality Perform Per the Intended Use as Defined in Protocol Section 5.1?"

  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 the management of fluid and gases, as well as removal, grasping, cutting, illumination, and coagulation of ocular materials during ocular surgery. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.

  Day 0

Secondary Outcomes (3)

• Mean Total Time in Eye

  Day 0 operative, up to surgery completion

• Percent of 'Yes' Responses to the Binary Question, "Was Anatomical Success Achieved for Intended Treatment?"

  Month 3 Postoperative

• Mean Change in Monocular Best Corrected Distance Visual Acuity (BCDVA) From Preoperative to Month 3

  Preoperative (Day -30 to 0), Month 3 Postoperative

Study Arms (1)

UNITY VCS

EXPERIMENTAL

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

Device: UNITY Vitreoretinal Cataract System; Procedure: Posterior segment surgery in the operating room with or without simultaneous cataract surgery

Interventions

UNITY Vitreoretinal Cataract System 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

Also known as: UNITY VCS

UNITY VCS

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

UNITY VCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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);

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (5)

NSW Retina Pty Ltd

Hurstville, New South Wales, 2220, Australia

Location

Southwest Retina

Liverpool, New South Wales, 2170, Australia

Location

Sydney Retina Clinic & Day Surgery

Sydney, New South Wales, 2000, Australia

Location

Adelaide Eye & Retina Centre

Adelaide, South Australia, 5000, Australia

Location

Pennington Eye Clinic

North Adelaide, South Australia, 5006, Australia

Location

Results Point of Contact

• Title: Sr. Principal Clinical Project Lead, Surgical
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Sr. Clinical Operations Lead, Surgical

  Alcon Research, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 11, 2023
• Study Start: February 27, 2024
• Primary Completion: May 23, 2024
• Study Completion: August 19, 2024
• Last Updated: June 25, 2025
• Results First Posted: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5)