UNITY VCS Vitreoretinal Surgery: Randomized Comparative Clinical Trial

Alcon

Status: Not yet enrolling

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

Treatments: Procedure: Vitreoretinal ophthalmic surgery; Device: CONSTELLATION Vision System; Device: UNITY Vitreoretinal Cataract System (VCS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07054281

CTV678-P001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

UNITY Vitreoretinal Cataract System (VCS)

Experimental group

Description:

Vitreoretinal ophthalmic surgery in one eye using UNITY Vitreoretinal Cataract System (VCS)

Treatment:

Device: UNITY Vitreoretinal Cataract System (VCS)

Procedure: Vitreoretinal ophthalmic surgery

CONSTELLATION Vision System

Active Comparator group

Description:

Vitreoretinal ophthalmic surgery in one eye using CONSTELLATION Vision System

Treatment:

Device: CONSTELLATION Vision System

Procedure: Vitreoretinal ophthalmic surgery