Next Generation Cataract and Vitreoretinal Surgery Study

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.

Study Overview

• Status: Completed
• Conditions: Vitreoretinal Disease With or Without Cataracts
• Intervention / Treatment: Device: UNITY Vitreoretinal Cataract System; Procedure: Posterior segment surgery in the operating room with or without simultaneous cataract surgery

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Hurstville, New South Wales, Australia, 2220
      • NSW Retina Pty Ltd
    • Liverpool, New South Wales, Australia, 2170
      • Southwest Retina
    • Sydney, New South Wales, Australia, 2000
      • Sydney Retina Clinic & Day Surgery
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Adelaide Eye & Retina Centre
    • North Adelaide, South Australia, Australia, 5006
      • Pennington Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key 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;
• Other protocol-defined inclusion criteria may apply.

Key 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);
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Device: 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; Other Names: UNITY VCS; Procedure: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Total Time in Eye	The time from first entry into eye/first trocar in to incision closure/last trocar out was measured using a stopwatch and recorded in minutes. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.	Day 0 operative, up to surgery completion
Percent of 'Yes' Responses to the Binary Question, "Was Anatomical Success Achieved for Intended Treatment?"	As reported by the examiner at the Month 3 visit. Intended treatment included macular hole closure, retinal attachment, etc. as applicable for the patient's condition. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.	Month 3 Postoperative
Mean Change in Monocular Best Corrected Distance Visual Acuity (BCDVA) From Preoperative to Month 3	Visual acuity was assessed with refractive correction in place using a Snellen visual acuity chart. Results were converted to decimal VA, where 2.00 decimal equates to 20/16 Snellen (better than normal distance eyesight), 1.00 decimal equates to 20/20 Snellen (normal distance eyesight), and 0.1 decimal equates to 6/600 Snellen (worse than normal distance eyesight). A positive change value indicates an improvement. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.	Preoperative (Day -30 to 0), Month 3 Postoperative

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Sr. Clinical Operations Lead, Surgical, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2024
• Primary Completion (Actual): May 23, 2024
• Study Completion (Actual): August 19, 2024

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Vitreoretinal surgery; Vitreoretinal with cataract surgery
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CTV678-E001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes