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Evaluation of the Safety and Performance of the HARMONI® Toric Lens

NCT03050697 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-06-12

Study results available
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Summary

The purpose of this study was to evaluate the safety and effectiveness of the HARMONI® Modular Intraocular Lens System with a toric optic (HMTIOL) in subjects with pre-existing corneal astigmatism in need of cataract surgery.

Conditions

  • Aphakia
  • Corneal Astigmatism
  • Cataract

Interventions

DEVICE

HARMONI® Modular Toric Intraocular Lens

Two-component system consisting of a base and a separate toric optic

PROCEDURE

Cataract extraction with intraocular lens (IOL) implantation

Cataract removal via manual phacoemulsification, followed by HMTIOL implantation

Sponsors & Collaborators

  • ClarVista Medical

    lead INDUSTRY

Principal Investigators

  • Sr. Clinical Trial Lead, CDMA Surgical · Alcon Research, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-28
Primary Completion
2017-06-07
Completion
2017-07-28
FDA Device
Yes

Countries

  • New Zealand

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 NCT03050697 on ClinicalTrials.gov