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A Comparative Study of TECNIS Symfony Plus IOL and a Trifocal IOL

NCT04156737 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2021-08-05

No results posted yet for this study

Summary

This is a multicenter, prospective, randomized, subject- and evaluator-masked, bilateral-implant study conducted at up to 15 sites worldwide. A total of up to 280 subjects will be randomized in a 1:1 ratio for implantation with either the TECNIS Symfony plus IOL Model ZHR00V or the Trifocal IOL. This will ensure that data from at least 100 subjects in the TECNIS Symfony plus lens group and at least 100 subjects in the Trifocal lens group will be available for analysis at the 6-month follow-up timepoint. All subjects will be followed for up to 6 months postoperative.

Conditions

  • Cataract
  • Refractive Error

Interventions

DEVICE

TECNIS Symfony plus IOL Model ZHR00V

IOL replaces the natural lens removed during cataract surgery

DEVICE

Trifocal Intraocular lens

IOL replaces the natural lens removed during cataract surgery

Sponsors & Collaborators

  • Johnson & Johnson Surgical Vision, Inc.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Surgical Vision Clinical Trials · Johnson & Johnson Surgical Vision

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-24
Primary Completion
2021-07-14
Completion
2021-07-14

Countries

  • New Zealand
  • Philippines
  • Spain

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 NCT04156737 on ClinicalTrials.gov