NCT03111550

Clinical Investigation of the Next-Generation Intraocular Lens

Clinical Investigation of the TECNIS Next-Generation Intraocular Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Abbott Medical Optics · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This study is a 6-month, prospective, multicenter, bilateral, randomized clinical investigation of the TECNIS Model ZHR00 and Model ZQR00 IOLs versus the TECNIS Symfony control IOL. The study was conducted at 12 sites in the U.S.A and treated approximately 240 subjects, equally split between the two test groups and the control group.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	Investigational Intraocular Lens Device #1: TECNIS Model ZHR00	Intraocular lens replaces the natural lens removed during cataract surgery.
DEVICE	Investigational Intraocular Lens Device #2: TECNIS Model ZQR00	Intraocular lens replaces the natural lens removed during cataract surgery.
DEVICE	TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00	Intraocular lens replaces the natural lens removed during cataract surgery.

Timeline

• Start date: 2017-05-10
• Primary completion: 2018-02-23
• Completion: 2018-02-23
• First posted: 2017-04-13
• Last updated: 2025-06-24
• Results posted: 2020-08-24

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated device study