NCT06377514

Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 245 (actual)
• Sponsor: Johnson & Johnson Surgical Vision, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

Prospective, multicenter, bilateral, interventional, controlled, masked (sponsor, subjects, and evaluators), randomized clinical trial.

Conditions

• Cataracts

Interventions

Type	Name	Description
DEVICE	Test IOL Model DEN00V	Eligible subjects will be randomized in a 1:1 ratio to receive the Test IOL Model DEN00V in both eyes for the duration of the study
DEVICE	Control IOL Model DCB00	Eligible subjects will be randomized in a 1:1 ratio to receive the control IOL Model DCB00 in both eyes for the duration of the study

Timeline

• Start date: 2024-06-03
• Primary completion: 2025-04-23
• Completion: 2025-04-23
• First posted: 2024-04-22
• Last updated: 2025-12-05

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study