UNITY VCS Vitreoretinal Surgery

NCT07054281 | Withdrawn FDA Device

• 1 other identifier: CTV678-P001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 8

Brief Summary

This purpose of this study is to compare the safety and effectiveness of two eye surgery systems-UNITY VCS and CONSTELLATION-in treating adults with vitreoretinal diseases or disorders.

Conditions

Macular Hole; Epiretinal Membrane; Retained Lens Material in the Posterior Segment; Visually Significant Vitreous Floater; Vitreomacular Traction; Vitreous Hemorrhage; Proliferative Diabetic Retinopathy; Rhegmatogenous Retinal Detachment

Keywords

Vitreoretinal Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of vitreoretinal surgeries performed using 27-gauge consumables

  The surgeon will select the gauge size of the surgical consumables used for vitreoretinal surgery

  Day 0 operative

Study Arms (2)

UNITY Vitreoretinal Cataract System (VCS)

EXPERIMENTAL

Vitreoretinal ophthalmic surgery in one eye using UNITY Vitreoretinal Cataract System (VCS)

Device: UNITY Vitreoretinal Cataract System (VCS); Procedure: Vitreoretinal ophthalmic surgery

CONSTELLATION Vision System

ACTIVE COMPARATOR

Vitreoretinal ophthalmic surgery in one eye using CONSTELLATION Vision System

Device: CONSTELLATION Vision System; Procedure: Vitreoretinal ophthalmic surgery

Interventions

UNITY Vitreoretinal Cataract System (VCS) DEVICE

UNITY VCS is a commercially approved surgical system that facilitates the management of fluid and gases, as well as removal, grasping, cutting, illumination, and coagulation of ocular materials during eye surgery. In this study, the UNITY VCS posterior segment functionalities will be used to perform posterior segment (i.e., vitreoretinal) ophthalmic surgery.

UNITY Vitreoretinal Cataract System (VCS)

CONSTELLATION Vision System DEVICE

CONSTELLATION is a commercially approved, multifunctional surgical instrument used during ophthalmic surgery to cut vitreous and tissues, emulsify the lens, illuminate the posterior segment of the eye, and apply diathermy to stop bleeding.

CONSTELLATION Vision System

Vitreoretinal ophthalmic surgery PROCEDURE

Ophthalmic surgery performed in the posterior segment of the eye

CONSTELLATION Vision System; UNITY Vitreoretinal Cataract System (VCS)

Eligibility Criteria

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

You may qualify if:

• Requires surgery for a clinically documented posterior vitreoretinal medical condition.
• Clear ocular media except for vitreous hemorrhage and floaters undergoing surgery.

You may not qualify if:

• Presence of clinically significant ocular or systemic diseases that may interfere with study outcomes or safety.
• Diagnosis of glaucoma or suspected ocular hypertension.
• Recent intraocular eye surgery, other than cataract surgery, resulting in retained lens materials in the posterior segment (within the past 3-months).

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (8)

Retina Macula Institute of Arizona

Scottsdale, Arizona, 85255, United States

Location

Retina Associates of Orange County

Laguna Hills, California, 92653, United States

Location

Wolfe Eye Clinic

West Des Moines, Iowa, 50266, United States

Location

Vision Research Center Eye Associates of New Mexico

Albuquerque, New Mexico, 87109, United States

Location

NYC Retina - Manhattan

New York, New York, 10003, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Charles Retina Institute

Germantown, Tennessee, 38138, United States

Location

The Eye Institute of Utah

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Epiretinal Membrane; Retinal Perforations; Vitreous Hemorrhage

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Eye Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trial Lead, Surgical

  Alcon Research, LLC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)