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Next Generation Cataract and Vitreoretinal Surgery Study

NCT06165744 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-06-25

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 formal user feedback.

Conditions

  • Vitreoretinal Disease With or Without Cataracts

Interventions

DEVICE

UNITY Vitreoretinal Cataract System

UNITY Vitreoretinal Cataract System (VCS) with console, remote control, foot controller, UNITY TOTAL PLUS Combined Procedure Pak, and additional devices as needed to complete surgery

PROCEDURE

Posterior segment surgery in the operating room with or without simultaneous cataract surgery

Posterior segment surgery involves removal of the vitreous (i.e., vitrectomy) followed by additional interventions as needed. Cataract surgery involves removal of the crystalline lens (which is often cloudy).

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Sr. Clinical Operations Lead, Surgical · Alcon Research, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-27
Primary Completion
2024-05-23
Completion
2024-08-19
FDA Device
Yes

Countries

  • Australia

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 NCT06165744 on ClinicalTrials.gov