Next Generation Cataract and Vitreoretinal Surgery Study

Not Applicable

Completed

• Conditions: Ophthalmic Surgery
• Interventions: Device: UNITY VCS; Procedure: Eye surgery

• Registration Number: NCT06165744
• Lead Sponsor: Alcon Research

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-04
• Study First Posted: 2023-12-11
• Study Start: 2024-02-27
• Primary Completion: 2024-05-25
• Status Verified: 2024-08
• Study Completion: 2024-08-19
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
UNITY VCS	Eye surgery	Eye surgery performed with UNITY VCS
UNITY VCS	UNITY VCS	Eye surgery performed with UNITY VCS

Primary Outcome Measures

Name	Time	Method
Percent of 'yes' responses to the binary question, "Did UNITY VCS using vitreoretinal or combined surgical functionality perform per the intended use as defined in protocol Section 5.1?"	Day 0 operative	As recorded by the surgeon on a user questionnaire

Secondary Outcome Measures

Name	Time	Method
Percent of 'yes' responses to the binary question, "Was anatomical success achieved for intended treatment (e.g., macular hole closure, retinal attachment, etc. as applicable for the patient's condition)?"	Month 3 Postoperative	As reported by the examiner
Total time in the eye	Day 0 operative	Total time in the eye (from first entry into eye/first trocar in, to incision closure/last trocar out) will be recorded
Change from preoperative in Best Corrected Distance Visual Acuity (BCDVA) at Month 3 postoperative	Preoperative (Day -30 to 0), Month 3 Postoperative	Visual acuity will be assessed with correction in place.

Trial Locations

Locations (6)

Retina Associates - Southwest Retina; 🇦🇺 Liverpool, New South Wales, Australia

Adelaide Eye & Retina Centre; 🇦🇺 Adelaide, South Australia, Australia

Retina and Macula Specialists; 🇦🇺 Hurstville, New South Wales, Australia

Sydney Retina Clinic & Day Surgery; 🇦🇺 Sydney, New South Wales, Australia

St John of God Eye Centre; 🇦🇺 Geelong, Victoria, Australia

Pennington Eye Clinic; 🇦🇺 North Adelaide, South Australia, Australia