Next Generation Cataract and Vitreoretinal Surgery Study

Alcon

Status

Completed

Conditions

Vitreoretinal Disease With or Without Cataracts

Treatments

Device: UNITY Vitreoretinal Cataract System

Procedure: Posterior segment surgery in the operating room with or without simultaneous cataract surgery

Study type

Interventional

Funder types

Industry

Identifiers

NCT06165744

CTV678-E001

Details and patient eligibility

About

The purpose of this study is to obtain device-specific safety and performance clinical data to support marketability in Europe and to collect formal user feedback.

Full description

Subjects will attend a screening visit (Day -30 to Day 0), a surgery visit (Day 0), and 4 post-surgical visits (Day 1, Week 1, Month 1, Month 3) for an overall individual duration of approximately 4 months. One eye (study eye) will be treated. This study will be conducted in Australia.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Requires posterior segment surgery in the operating room with or without simultaneous cataract surgery;
Clear media except for cataract and vitreous hemorrhage;
In simultaneous cataract and vitreoretinal surgery, eligible to undergo primary hydrophobic acrylic intraocular lens (IOL) implantation into the capsular bag;
Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

Previous vitrectomy in the operative eye aside from those requiring silicone oil removal;
Neovascular or uncontrolled glaucoma;
Planned glaucoma or postoperative surgeries during study aside from silicone oil removal;
Inadequate pupil dilation (less than 6 millimeters);
Other protocol-defined exclusion criteria may apply.