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Post-Approval Study of the Tecnis® Toric IOL

NCT02566083 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 365

Last updated 2020-01-18

Study results available
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Summary

This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative clinical study conducted at up to 80 sites in the USA. Subjects will choose to be bilaterally implanted with either 1) the TECNIS 1-Piece Toric IOLs, Model ZCT300 and/or ZCT400, or 2) the TECNIS Monofocal Model ZCB00 non-toric control IOL, according to subject preference

Conditions

  • Cataract

Interventions

DEVICE

non-toric intraocular lens

TECNIS One-piece Monofocal Model ZCB00

DEVICE

toric intraocular lens

TECNIS One-piece Toric Models ZCT300 or ZCT400

Sponsors & Collaborators

  • Abbott Medical Optics

    lead INDUSTRY

Principal Investigators

  • Devi Priya Janakiraman, OD, FAAO · Johnson & Johnson Surgical Vision

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-21
Primary Completion
2018-12-11
Completion
2019-05-23
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT02566083 on ClinicalTrials.gov