UNITY VCS Vitreoretinal Surgery: Randomized Comparative Clinical Trial

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07054281
• Lead Sponsor: Alcon Research

Brief 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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-27
• Study First Submitted QC: 2025-06-27
• Last Update Submitted: 2025-06-27
• Study Start: 2025-07-01
• Study First Posted: 2025-07-08
• Last Update Posted: 2025-07-08
• Primary Completion: 2026-04
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• Requires surgery for a clinically documented posterior vitreoretinal medical condition.
• Clear ocular media except for vitreous hemorrhage and floaters undergoing surgery.
• Other protocol-specified inclusion criteria may apply.

Key

Exclusion Criteria

• Presence of clinically significant ocular or systemic diseases that may interfere with study outcomes or safety.
• Diagnosis of glaucoma or suspected ocular hypertension.
• Recent intraocular eye surgery, other than cataract surgery, resulting in retained lens materials in the posterior segment (within the past 3-months).
• Other protocol-specified exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of vitreoretinal surgeries performed using 27-gauge consumables	Day 0 operative	The surgeon will select the gauge size of the surgical consumables used for vitreoretinal surgery

Trial Locations

Locations (8)

Retina Macula Institute of Arizona; 🇺🇸 Scottsdale, Arizona, United States

Retina Associates of Orange County; 🇺🇸 Laguna Hills, California, United States

Wolfe Eye Clinic; 🇺🇸 West Des Moines, Iowa, United States

Vision Research Center Eye Associates of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States

NYC Retina - Manhattan; 🇺🇸 New York, New York, United States

Black Hills Regional Eye Institute; 🇺🇸 Rapid City, South Dakota, United States

Charles Retina Institute; 🇺🇸 Germantown, Tennessee, United States

The Eye Institute of Utah; 🇺🇸 Salt Lake City, Utah, United States