NCT05090787

Clinical Investigation of the TECNIS 1-Piece Intraocular Lens

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (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, comparative, multicenter, bilateral, parallel group, randomized (2:1), subject/evaluator masked clinical investigation of the investigational mDCB00 IOL as compared to the DCB00 IOL. The study will be conducted at up to 8 sites in countries where both the investigational and control lenses are approved for market and/or for evaluation in a clinical study and will include a total of up to 200 subjects. Subjects will be randomly assigned to receive either the test lens or the control lens in both eyes.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	Investigational mDCB00	Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
DEVICE	Control DCB00	Control intraocular lens replaces the natural lens removed during cataract surgery in both eyes

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2021-10-25
• Last updated: 2024-02-06

Regulatory

• FDA-regulated device study