NCT03372434

Clinical Investigation of the Next-Generation Intraocular Lenses

Clinical Investigation of the TECNIS Next-Generation Intraocular Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Abbott Medical Optics · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

This study is a 6-month, prospective, multicenter, subject/evaluator-masked, bilateral, randomized clinical investigation of the TECNIS Next-Generation Model ZFR00 and Model ZYR00 IOLs versus the TECNIS Multifocal Model ZLB00 control IOL. The study will be conducted at up to 14 sites in the U.S.A and will enroll up to 260 subjects to achieve approximately 220 randomized and bilaterally-implanted subjects, resulting in approximately 195 evaluable subjects (65 in each test group and 65 in the control group) at 1 and 6 months. Subjects are to be implanted with the same IOL in both eyes, the ZFR00 IOL, the ZYR00 IOL or the ZLB00 control IOL. The eye implanted first will be considered the primary study eye.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	Investigational Intraocular Lens Device #1: Model ZFR00	IOL replaces the natural lens removed during cataract surgery.
DEVICE	Investigational Intraocular Lens Device #1: Model ZYR00	IOL replaces the natural lens removed during cataract surgery.
DEVICE	TECNIS Multifocal Intraocular Lens: Model ZLB00	IOL replaces the natural lens removed during cataract surgery.

Timeline

• Start date: 2018-01-16
• Primary completion: 2018-07-11
• Completion: 2018-10-30
• First posted: 2017-12-13
• Last updated: 2025-06-24
• Results posted: 2021-07-27

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated device study