Clinical trial NCT06165744: Next Generation Cataract and Vitreoretinal Surgery Study
Official title: Next Generation Cataract and Vitreoretinal Surgery Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ophthalmic Surgery
Keywords: Eye surgery
Cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-12-11
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 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?"
timeFrame: Day 0 operative
Secondary outcomes:
measure: Total time in the eye
timeFrame: Day 0 operative
measure: 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)?"
timeFrame: Month 3 Postoperative
measure: Change from preoperative in Best Corrected Distance Visual Acuity (BCDVA) at Month 3 postoperative
timeFrame: Preoperative (Day -30 to 0), Month 3 Postoperative
Other outcomes:
Locations:
city: Hurstville
country: Australia
facility: Retina and Macula Specialists
state: New South Wales
city: Liverpool
country: Australia
facility: Retina Associates - Southwest Retina
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Retina Clinic & Day Surgery
state: New South Wales
city: Adelaide
country: Australia
facility: Adelaide Eye & Retina Centre
state: South Australia
city: North Adelaide
country: Australia
facility: Pennington Eye Clinic
state: South Australia
city: Geelong
country: Australia
facility: St John of God Eye Centre
state: Victoria
Study officials:
affiliation: Alcon Research, LLC
name: Sr. Clinical Operations Lead, Surgical
role: STUDY_DIRECTOR
References: