NCT05036070

Proof-of-concept Study for a New Intraocular Lens, MODEL C0001

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Johnson & Johnson Surgical Vision, Inc. · Industry
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a 12-month, prospective, 2-arm (1 test \& 1 control), randomized (1 test:1 control), bilateral, subject/evaluator-masked clinical investigation of the EPV IOL versus the standard TECNIS monofocal control IOL. The study will be conducted at a minimum of one to a maximum of five sites in France, with a total of 40 evaluable subjects for the investigational lens group and 40 evaluable subjects for the control lens group participating in the sub-study. The peripheral and functional testing will be conducted on a sub-group of subjects who achieve binocular uncorrected distance visual acuity (UCDVA) of 0.2 logMAR or better and/or are able to perform the driving simulator-sickness testing as determined by patient response to the SSQ (Appendix D) at the first 1-month visit. The eye implanted first will be considered the primary study eye (first eye). Subjects will be randomized to either the investigational IOL Model C0001 or the control IOL Model ZCB00 in both eyes.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	Model C0001	Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
DEVICE	Model ZCB00	Control intraocular lens replaces the natural lens removed during cataract surgery in both eyes.

Timeline

• Start date: 2021-11-18
• Primary completion: 2024-04-24
• Completion: 2024-04-24
• First posted: 2021-09-05
• Last updated: 2025-05-23

Locations

2 sites across 1 country: France