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Visual and Refractive Outcomes of The ClarVista HARMONI™ Modular Intraocular Lens System (HMIOL)

NCT03681886 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-01-05

Study results available
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Summary

The purpose of this study was to evaluate visual and refractive outcomes with the use of the HARMONI™ Modular Intraocular Lens (HMIOL) System implantation, assembly, and optic exchange in subjects undergoing cataract surgery.

Conditions

  • Cataract
  • Aphakia

Interventions

DEVICE

Harmoni Modular Intraocular Lens

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

Optic Exchange

Removal of one optic and replacement with another 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
2016-01-09
Primary Completion
2017-12-14
Completion
2017-12-14
FDA Device
Yes

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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 NCT03681886 on ClinicalTrials.gov