Status:
COMPLETED
Next Generation Cataract and Vitreoretinal Surgery Study
Lead Sponsor:
Alcon Research
Conditions:
Vitreoretinal Disease With or Without Cataracts
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed 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 m...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
February 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06165744
Start Date
February 27 2024
End Date
August 19 2024
Last Update
June 25 2025
Active Locations (5)
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1
NSW Retina Pty Ltd
Hurstville, New South Wales, Australia, 2220
2
Southwest Retina
Liverpool, New South Wales, Australia, 2170
3
Sydney Retina Clinic & Day Surgery
Sydney, New South Wales, Australia, 2000
4
Adelaide Eye & Retina Centre
Adelaide, South Australia, Australia, 5000