UNITY VCS Vitreoretinal Surgery

UNITY VCS Vitreoretinal Surgery: Randomized Comparative Clinical Trial

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.

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.

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.