Trials / Withdrawn

WithdrawnNCT07054281

UNITY VCS Vitreoretinal Surgery

UNITY VCS Vitreoretinal Surgery: Randomized Comparative Clinical Trial

Status: Withdrawn
Phase: N/A
Study type: Interventional
Enrollment: 0 (actual)

Sponsor: Alcon Research · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

Subjects will attend a total of 6 scheduled visits for an individual of participation of approximately 3 months. One eye (study eye) will be treated with either UNITY VCS or CONSTELLATION, as randomized.

Conditions

Interventions

Type	Name	Description
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

Timeline

Start date: 2026-01-01
Primary completion: 2026-10-01
Completion: 2027-02-01
First posted: 2025-07-08
Last updated: 2025-12-12

Locations

8 sites across 1 country: United States

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT07054281. Inclusion in this directory is not an endorsement.