MedTrace Logo

Clinical Investigation of the Next-Generation Intraocular Lens

NCT03111550 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2025-06-24

Study results available
· View outcomes & findings →

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

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.

Sponsors & Collaborators

  • Abbott Medical Optics

    lead INDUSTRY

Principal Investigators

  • Devi Priya Janakiraman, OD,FAAO · Abbott Medical Optics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-10
Primary Completion
2018-02-23
Completion
2018-02-23
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03111550 on ClinicalTrials.gov