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

NCT ID: NCT03681886

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-09
• Study Completion Date: 2017-12-14

Brief 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.

Detailed Description

All subjects were implanted with the HARMONI™ Modular Intraocular Lens (HMIOL) System in the right eye, left eye, or both eyes based on the best interest of the subject and the clinical judgment the Investigator (Day 0, primary implantation) (Cohort 1). At Month 1 post primary implantation, subjects were given the option to undergo an optic exchange procedure. Subjects who underwent the optic exchange (Cohort 2) (Day 0, optic exchange) were followed for an additional month. Subjects who did not undergo an optic exchange were exited from the study, except at 1 site, which followed subjects up to Month 12.

Alcon Research, LLC, acquired ClarVista Medical in 2017. This study was designed and conducted by ClarVista Medical, Inc. The study results were collected, analyzed, and provided by ClarVista Medical, Inc. to Alcon Research, LLC.

Conditions

Cataract; Aphakia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Primary Implantation (Cohort 1)

Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.

Group Type: EXPERIMENTAL

Harmoni Modular Intraocular Lens

Intervention Type: DEVICE

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.

Optic Exchange (Cohort 2)

Subset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchange

Group Type: EXPERIMENTAL

Harmoni Modular Intraocular Lens

Intervention Type: DEVICE

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.

Optic Exchange

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: DEVICE

Optic Exchange

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

Intervention Type: PROCEDURE

Other Intervention Names

HMIOL

Eligibility Criteria

Inclusion Criteria

• Able to understand and sign an approved Informed Consent Form (ICF);
• Willing and able to return for scheduled treatment and follow-up examinations;
• Planned removal of cataracts (cortical, nuclear, subcapsular, or a combination) by manual phacoemulsification cataract extraction;

Exclusion Criteria

• Any ocular conditions which could affect the stability of the IOL in either eye;
• Traumatic or congenital cataract;
• Pregnancy or planned pregnancy during the study period;
• Medications that may confound the outcome or increase risk to the subject;
• Any clinical finding or intraocular complication during primary cataract surgery or Implantation of the lens system likely to increase complications or risk to the subject;

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ClarVista Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sr. Clinical Trial Lead, CDMA Surgical

Role: STUDY_DIRECTOR

Alcon Research, LLC

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

CVM-00001

Identifier Type: -

Identifier Source: org_study_id