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UNITY VCS Vitreoretinal Surgery | Clinical Trials | Clareo Health

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UNITY VCS Vitreoretinal Surgery

UNITY VCS Vitreoretinal Surgery: Randomized Comparative Clinical Trial

NCT07054281•Alcon Research

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.

Detailed Description

Subjects will attend a total of 6 scheduled visits for an individual of participation of approximately 3 months. One eye (study eye) will be treated with either UNITY VCS or CONSTELLATION, as randomized.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria

•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).

Locations (8)

Retina Macula Institute of Arizona

Scottsdale, Arizona, United States

Retina Associates of Orange County

Laguna Hills, California, United States

Wolfe Eye Clinic

West Des Moines, Iowa, United States

Vision Research Center Eye Associates of New Mexico

Albuquerque, New Mexico, United States

NYC Retina - Manhattan

New York, New York, United States

Black Hills Regional Eye Institute

Rapid City, South Dakota, United States

Charles Retina Institute

Germantown, Tennessee, United States

The Eye Institute of Utah

Salt Lake City, Utah, United States

Key Dates

Start Date

January 1, 2026

Primary Completion Date

October 1, 2026

Completion Date

February 1, 2027

Last Updated

December 12, 2025

Conditions

Epiretinal MembraneMacular HoleVisually Significant Vitreous FloaterVitreomacular TractionVitreous HemorrhageProliferative Diabetic RetinopathyRhegmatogenous Retinal DetachmentRetained Lens Material in the Posterior Segment

Interventions

UNITY Vitreoretinal Cataract System (VCS)

DEVICE

CONSTELLATION Vision System

DEVICE

Vitreoretinal ophthalmic surgery

PROCEDURE

Functional IOL Implantation in Patients with Epiretinal Membrane

NCT06719739

CataractIntraocular Lens Complication+1 more

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ENROLLING_BY_INVITATIONNA

Intraocular Gas Tamponade for Treatment of Large Idiopathic Macular Holes

NCT06927544

Idiopathic Macular HoleMacular Hole+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

UNITY VCS Vitreoretinal Surgery

Inclusion Criteria

Exclusion Criteria

Functional IOL Implantation in Patients with Epiretinal Membrane

Intraocular Gas Tamponade for Treatment of Large Idiopathic Macular Holes

The Use of Amniotic Membrane or Internal Limiting Membrane for Large or Refractory Macular Holes: A Prospective Study

Subjective Pain Scoring for Subtenonal Anesthesia During Vitrectomy

" Sweeper " and Epiretinal Membrane Surgery

Ocular Coherence Tomography During Cataract Assessment