Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens
NCT06377514 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 245
Last updated 2025-12-05
Summary
Prospective, multicenter, bilateral, interventional, controlled, masked (sponsor, subjects, and evaluators), randomized clinical trial.
Conditions
- Cataracts
Interventions
- 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
Sponsors & Collaborators
-
Johnson & Johnson Surgical Vision, Inc.
lead INDUSTRY
Principal Investigators
-
Johnson & Johnson Surgical Vision, Inc. Clinical Trial · Johnson & Johnson Surgical Vision, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-06-03
- Primary Completion
- 2025-04-23
- Completion
- 2025-04-23
- FDA Device
- Yes
Countries
- United States
Study Locations
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