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UNITY VCS Vitreoretinal Surgery

NCT07054281 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-12-12

No results posted yet for this study

Summary

This purpose of this study is to compare the safety and effectiveness of two eye surgery systems-UNITY VCS and CONSTELLATION-in treating adults with vitreoretinal diseases or disorders.

Conditions

  • Epiretinal Membrane
  • Macular Hole
  • Visually Significant Vitreous Floater
  • Vitreomacular Traction
  • Vitreous Hemorrhage
  • Proliferative Diabetic Retinopathy
  • Rhegmatogenous Retinal Detachment
  • Retained Lens Material in the Posterior Segment

Interventions

DEVICE

UNITY Vitreoretinal Cataract System (VCS)

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. In this study, the UNITY VCS posterior segment functionalities will be used to perform posterior segment (i.e., vitreoretinal) ophthalmic surgery.

DEVICE

CONSTELLATION Vision System

CONSTELLATION is a commercially approved, multifunctional surgical instrument used during ophthalmic surgery to cut vitreous and tissues, emulsify the lens, illuminate the posterior segment of the eye, and apply diathermy to stop bleeding.

PROCEDURE

Vitreoretinal ophthalmic surgery

Ophthalmic surgery performed in the posterior segment of the eye

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Clinical Trial Lead, Surgical · Alcon Research, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-10-31
Completion
2027-02-28
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 NCT07054281 on ClinicalTrials.gov