Next Generation Cataract and Vitreoretinal Surgery Study

Alcon

Status: Completed

Conditions: Ophthalmic Surgery

Treatments: Procedure: Eye surgery; Device: UNITY VCS

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 and to collect formal user feedback.

Full description

Eligible subjects will be expected to attend 6 scheduled visits (Day -30 to 0 Screening, Day 0 Operative, Day 1 Postoperative, Week 1 Postoperative, Month 1 Postoperative, and Month 3 Postoperative) for a total individual duration for participation of approximately 4 months. One eye (study eye) will undergo ophthalmic surgery.

Enrollment: 119 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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119 participants in 1 patient group

UNITY VCS

Experimental group

Description:

Eye surgery performed with UNITY VCS

Treatment:

Device: UNITY VCS

Procedure: Eye surgery