Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens

Not Applicable

Active, not recruiting

• Conditions: Cataracts
• Interventions: Device: Control IOL Model DCB00; Device: Test IOL Model DEN00V

• Registration Number: NCT06377514
• Lead Sponsor: Johnson & Johnson Surgical Vision, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-17
• Study First Posted: 2024-04-22
• Study Start: 2024-06-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-07-27
• Study Completion: 2025-07-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control IOL	Control IOL Model DCB00	DCB00
Test IOL	Test IOL Model DEN00V	DEN00V

Primary Outcome Measures

Name	Time	Method
Monocular Photopic DCVA at 100 cm	6 months	Monocular photopic DCVA at 100 cm for first eyes at 6 months
Monocular photopic DCIVA (first eyes) at 66 cm	6 months	Mean DCIVA (logMAR) in test lens group is statistically significantly better (smaller) than in the control lens group
Monocular Depth of Focus	6 months	Monocular depth of defocus where visual acuity is 0.20 logMAR or better (measured only negative direction from zero) for first eyes at 6 months
Monocular Photopic BCDVA at 4m	6 months	Monocular photopic BCDVA at 4 meters for first eyes at 6 months

Secondary Outcome Measures

Name	Time	Method
Monocular photopic DCNVA at 40 cm (first eyes)	6 months	Mean DCNVA (logMAR) in the test lens group is statistically significantly better (smaller) than in the control lens group

Trial Locations

Locations (9)

Levenson Eye Associates; 🇺🇸 Jacksonville, Florida, United States

Jones Eye Center; 🇺🇸 Sioux City, Iowa, United States

OCLI Vision; 🇺🇸 Garden City, New York, United States

Cleveland Eye Clinic; 🇺🇸 Brecksville, Ohio, United States

Whitsett Vision Group; 🇺🇸 Houston, Texas, United States

Parkhurst NuVision; 🇺🇸 San Antonio, Texas, United States

Empire Eye & Laser Center; 🇺🇸 Bakersfield, California, United States

Vance Thompson Vision; 🇺🇸 Sioux Falls, South Dakota, United States

Berkeley Eye Center; 🇺🇸 Houston, Texas, United States