ClarVista HARMONI Toric Trial With Intraoperative Exchange

ClarVista Medical

Status: Completed

Conditions: Cataract; Corneal Astigmatism; Aphakia

Treatments: Device: HARMONI® Modular Intraocular Lens System; Procedure: Intraoperative optic exchange

Study type: Interventional

Funder types: Industry

Identifiers

NCT03054649

CP-00002

Details and patient eligibility

About

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.

Full description

Subjects were implanted with the HARMONI® Modular Intraocular Lens System (HMIOL). The eye with the higher corneal astigmatism (study eye) was assigned to Cohort 1 and received the HARMONI® Modular Intraocular Lens System with a toric optic. The fellow eye was assigned to Cohort 2 and received the HARMONI® Modular Intraocular Lens System with a non-toric optic during primary implantation, which was replaced with the appropriate optic power (toric or non-toric) during an intraoperative exchange (IOE) procedure. A total of 7 study visits were planned, including a preoperative visit, operative visits for each eye, and 4 follow-up visits at 1 day, 1 week, 1 month, and 3 months postoperative. The total duration of participation for each subject was up to 6 months, which included a Day -90 to Day -0 preoperative period.

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: 44 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria

• Willing and able to return for scheduled treatment and follow-up examinations for up to 6 month study duration.
• Planned removal of visually significant bilateral cataracts.
• Pre-existing corneal astigmatism in at least 1 eye.
• Willing to discontinue contact lens wear for the duration of the study.
• Best Corrected Visual Acuity (BCVA) projected to be 0.2 logarithm Minimum Angle of Resolution (logMAR) or lower.
• Visual symptoms related to cataracts.

Key Exclusion Criteria

• History of any intraocular or corneal surgery in either eye (including refractive).
• Pregnant or lactating.
• History of any clinically significant retinal pathology or ocular diagnosis in either eye that could alter or limit final postoperative visual prognosis.
• History of any ocular condition which could affect the stability of the intraocular lens (IOL) in either eye.
• Uncontrolled glaucoma in either eye (per Investigator judgement).
• Severe dry eye that, in the opinion of the investigator, would impair the ability to obtain reliable study measurements

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange

Treatment:

Device: HARMONI® Modular Intraocular Lens System

Cohort 2

Experimental group

Description:

Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric or non-toric optic)

Treatment:

Procedure: Intraoperative optic exchange

Device: HARMONI® Modular Intraocular Lens System