UNITY VCS Vitreoretinal Surgery

Alcon Research

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

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

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.

CONSTELLATION Vision SystemDEVICE

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.

Vitreoretinal ophthalmic surgeryPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Requires surgery for a clinically documented posterior vitreoretinal medical condition. * Clear ocular media except for vitreous hemorrhage and floaters undergoing surgery. * Other protocol-specified inclusion criteria may apply. Key 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). * Other protocol-specified exclusion criteria may apply.

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

Outcomes

Primary Outcomes

Percentage of vitreoretinal surgeries performed using 27-gauge consumables

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

Time frame: Day 0 operative

Data from ClinicalTrials.gov

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