NCT03054649

ClarVista HARMONI Toric Trial With Intraoperative Exchange

A Prospective, Multicenter Study to Evaluate the Safety and Performance of the Exchangeable ClarVista HARMONI Modular Toric Intraocular Lens System for the Treatment of Pre-Existing Corneal Astigmatism and Aphakia Following Cataract Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: ClarVista Medical · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Cataract
• Corneal Astigmatism
• Aphakia

Interventions

Type	Name	Description
DEVICE	HARMONI® Modular Intraocular Lens System	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	Intraoperative optic exchange	Removal of one optic and replacement with another during cataract surgery for the purpose of improving refractive outcomes

Timeline

• Start date: 2016-06-28
• Primary completion: 2017-07-18
• Completion: 2017-07-18
• First posted: 2017-02-15
• Last updated: 2020-06-22
• Results posted: 2020-06-22

Locations

2 sites across 2 countries: Mexico, Philippines

Regulatory

• FDA-regulated device study