A Cataract Surgery Clinical Trial

Alcon Research

Overview

The purpose of the study is to compare the efficiency and safety of UNITY™ Vitreoretinal Cataract System (UNITY VCS) to CENTURION® Vision System with Active Sentry (CAS) in adult subjects with grade 2 or greater nuclear sclerotic cataracts who require phacoemulsification in both eyes. Subjects will attend a total of 8 scheduled visits for an individual duration of participation of approximately 1 month.

In this contralateral eye clinical study, one eye will undergo surgery with UNITY VCS and the other eye will undergo surgery with CAS. The second eye surgery will occur 0 to 14 days after the first eye surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Cataract

Interventions

UNITY Vitreoretinal Cataract SystemDEVICE

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. It consists of a console, remote control, foot controller, video overlay, and compatible anterior segment devices. In this study, it will be used for the removal of cataracts.

CENTURION Vision System with Active SentryDEVICE

CAS is a commercially approved surgical system for use during anterior segment ophthalmic surgery. It consists of a console, foot controller, remote control, video overlay, and compatible anterior segment devices. The Active Sentry handpiece will be used.

Anterior segment ophthalmic surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Clinically documented diagnosis of age-related nuclear sclerotic cataract of grade 2 or greater in both eyes; * Both eyes with similar nuclear sclerotic cataract severity and type (within 1 cataract grade); * Both eyes able to be implanted with same intraocular lens material; * Both eyes able to receive the same ophthalmic viscosurgical device (OVD). * Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: * Planned intraoperative glaucoma surgery or expected postoperative procedures during the study in either study eye; * Laser-assisted cataract surgery in either study eye; * Any ocular disease and/or condition that, in the investigator's clinical judgement, may put the subject at significant risk, may compromise study results, or may interfere significantly with the subject's participation in the study. * Other protocol-specified exclusion criteria may apply.

Locations (5)

Wolfe Eye Clinic

West Des Moines, Iowa, United States

Vance Thompson Vision

Sioux Falls, South Dakota, United States

Whitsett Vision Group

Spring, Texas, United States

Berkeley Eye Center

Sugar Land, Texas, United States

Outcomes

Primary Outcomes

Cumulative Dissipated Energy (CDE)

Cumulative Dissipated Energy (CDE) is the measure of energy released at the level of the corneal incision during cataract surgery. CDE will be recorded by the system.

Time frame: Day 0 surgery, each eye

Data from ClinicalTrials.gov

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