NCT05025345

Vision Performance Evaluation of TECNIS EYHANCE™ With TECNIS SIMPLICITY™ Compared to TECNIS® 1-piece Intraocular Lenses

Clinical Evaluation of the Vision Performance of TECNIS EYHANCE™ Intraocular Lenses With TECNIS SIMPLICITY™ as Compared to TECNIS® 1-piece Intraocular Lenses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 228 (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, bilateral, randomized subject- and evaluator-masked, clinical investigation of the TECNIS Eyhance IOL versus the TECNIS 1-piece IOL. The study will be conducted at up to 15 sites in the U.S.A and will enroll approximately 220 subjects to achieve approximately 200 randomized and bilaterally implanted subjects, resulting in approximately 100 evaluable subjects in each lens group at 6 months. Subjects are to be implanted with the same IOL in both eyes: TECNIS Eyhance IOL or the TECNIS 1-Piece IOL. The eye implanted first will be considered the primary study eye.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	Tecnis Eyhance	Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
DEVICE	Tecnis 1 piece IOL	Control intraocular lens replaces the natural lens removed during cataract surgery in both eyes.

Timeline

• Start date: 2021-09-02
• Primary completion: 2022-06-17
• Completion: 2022-06-17
• First posted: 2021-08-27
• Last updated: 2023-08-28
• Results posted: 2023-08-28

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study