A Cataract Surgery Clinical Trial

NCT07044674 | Withdrawn FDA Device

• 1 other identifier: CTV678-P002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Cataract

Keywords

Phacoemulsification; Anterior segment

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0 surgery, each eye

Study Arms (2)

UNITY Vitreoretinal Cataract System (VCS)

EXPERIMENTAL

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

Device: UNITY Vitreoretinal Cataract System; Procedure: Anterior segment ophthalmic surgery

CENTURION Vision System with Active Sentry (CAS)

ACTIVE COMPARATOR

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

Device: CENTURION Vision System with Active Sentry; Procedure: Anterior segment ophthalmic surgery

Interventions

UNITY Vitreoretinal Cataract System 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.

Also known as: VCS

UNITY Vitreoretinal Cataract System (VCS)

Anterior segment ophthalmic surgery 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); UNITY Vitreoretinal Cataract System (VCS)

CENTURION Vision System with Active Sentry 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.

Also known as: CAS

CENTURION Vision System with Active Sentry (CAS)

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (5)

Wolfe Eye Clinic

West Des Moines, Iowa, 50266, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

Whitsett Vision Group

Spring, Texas, 77388, United States

Location

Berkeley Eye Center

Sugar Land, Texas, 77478, United States

Location

The Eye Institute of Utah

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Clinical Trial Lead, Surgical

  Alcon Research, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 1, 2025
• Study Start: February 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)