NCT04890249

Clinical Investigation of Two Tecnis Investigational Lenses

Clinical Investigation of the TECNIS® Intraocular Lens, Models C1V000 and C2V000

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: Johnson & Johnson Surgical Vision, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This study is a 6-month, prospective, multicenter, randomized (1:1:1), subject-masked and evaluator-masked, bilateral clinical investigation of the TECNIS IOL Models C1V000 and C2V000 versus the TECNIS Eyhance™ Model ICB00 IOL. The study will be conducted at up to 15 sites in EU, AU, NZ and/or AP and will enroll up to 225 subjects to achieve approximately 67 bilaterally implanted subjects in each lens group. Allowing for 10% lost-to-follow-up, this will achieve approximately 60 evaluable subjects in each lens group at 1, 3, and 6 months. The eye implanted first will be considered the primary (monocular) study eye.

Conditions

• Cataract
• Corneal Astigmatism

Interventions

Type	Name	Description
DEVICE	Investigational IOL Model C1V000	IOL replaces the natural lens removed during cataract surgery.
DEVICE	Investigational IOL Model C2V000	IOL replaces the natural lens removed during cataract surgery.
DEVICE	Control IOL Model ICB00	IOL replaces the natural lens removed during cataract surgery.

Timeline

• Start date: 2021-06-23
• Primary completion: 2023-01-31
• Completion: 2023-01-31
• First posted: 2021-05-18
• Last updated: 2025-05-23

Locations

8 sites across 2 countries: Australia, New Zealand