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

ClarVista Medical

Status: Completed

Conditions: Cataract; Aphakia

Treatments: Procedure: Optic Exchange; Device: Harmoni Modular Intraocular Lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT03681886

CVM-00001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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;

Key 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;
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Primary Implantation (Cohort 1)

Experimental group

Description:

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

Treatment:

Device: Harmoni Modular Intraocular Lens

Optic Exchange (Cohort 2)

Experimental group

Description:

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

Treatment:

Procedure: Optic Exchange

Device: Harmoni Modular Intraocular Lens