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Next Generation Cataract Surgery Study

NCT06071104 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2025-06-04

Study results available
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Summary

The purpose of this study is to obtain device-specific safety and performance clinical data to support marketability in Europe and to collect user preference data.

Conditions

  • Cataract

Interventions

PROCEDURE

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)

DEVICE

UNITY VCS

UNITY Vitreoretinal Cataract System (VCS) with console, remote control, foot controller, UNITY Cataract FMS Pack, and UNITY Anterior Vitrectomy Kit

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Clinical Trial Lead, CRD Surgical · Alcon Research, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-06
Primary Completion
2024-05-23
Completion
2024-06-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06071104 on ClinicalTrials.gov