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A Clinical Investigation of the ClarVista HARMONI™ Modular Intraocular Lens Implant Following Cataract Surgery

NCT02521766 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2020-05-14

Study results available
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Summary

The main objectives of this feasibility study were:

* To demonstrate the feasibility of HARMONI Modular Intraocular Lens (HMIOL) implantation and assembly in subjects undergoing cataract surgery (All HMIOL Cohort), and
* To demonstrate the feasibility of the HMIOL optic component exchange procedure (performed 3 months following primary cataract extraction) (Cohort 2).

Conditions

  • Cataract

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

DEVICE

Commercially Available Intraocular Lens

IOL per investigator's standard of care

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. CDMA Project Lead, Surgical · Alcon Research, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-01
Primary Completion
2017-02-07
Completion
2017-10-26
FDA Device
Yes

Countries

  • New Zealand
  • Philippines

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 NCT02521766 on ClinicalTrials.gov