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ClarVista HARMONI Toric Trial With Intraoperative Exchange

NCT03054649 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2020-06-22

Study results available
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Summary

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

Conditions

  • Cataract
  • Corneal Astigmatism
  • Aphakia

Interventions

DEVICE

HARMONI® Modular Intraocular Lens System

Two-component system consisting of a base and a separate optic that allows for an intraoperative exchange of the optic only without direct manipulation of the capsular bag

PROCEDURE

Intraoperative optic exchange

Removal of one optic and replacement with another during cataract surgery for the purpose of improving refractive outcomes

Sponsors & Collaborators

  • ClarVista Medical

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-28
Primary Completion
2017-07-18
Completion
2017-07-18
FDA Device
Yes

Countries

  • Mexico
  • Philippines

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 NCT03054649 on ClinicalTrials.gov