A Cataract Surgery Clinical Trial

NCT ID: NCT07044674

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cataract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

UNITY Vitreoretinal Cataract System (VCS)

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

Group Type EXPERIMENTAL

UNITY Vitreoretinal Cataract System

Intervention Type 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. 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.

Anterior segment ophthalmic surgery

Intervention Type PROCEDURE

Cataract surgery during which the crystalline lens (often cloudy) is broken into small pieces and gently removed from the eye with suction (phacoemulsification)

CENTURION Vision System with Active Sentry (CAS)

Anterior segment ophthalmic surgery in one eye using CENTURION Vision System with Active Sentry (CAS)

Group Type ACTIVE_COMPARATOR

CENTURION Vision System with Active Sentry

Intervention Type DEVICE

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

Intervention Type PROCEDURE

Cataract surgery during which the crystalline lens (often cloudy) is broken into small pieces and gently removed from the eye with suction (phacoemulsification)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

UNITY Vitreoretinal Cataract System

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.

Intervention Type DEVICE

CENTURION Vision System with Active Sentry

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.

Intervention Type DEVICE

Anterior segment ophthalmic surgery

Cataract surgery during which the crystalline lens (often cloudy) is broken into small pieces and gently removed from the eye with suction (phacoemulsification)

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

VCS CAS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trial Lead, Surgical

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wolfe Eye Clinic

West Des Moines, Iowa, United States

Site Status

Vance Thompson Vision

Sioux Falls, South Dakota, United States

Site Status

Whitsett Vision Group

Spring, Texas, United States

Site Status

Berkeley Eye Center

Sugar Land, Texas, United States

Site Status

The Eye Institute of Utah

Salt Lake City, Utah, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CTV678-P002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cataract Refractive Suite Study
NCT02974140 TERMINATED NA