CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
HARMONI® Modular Intraocular Lens System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03054649
NCT03054649N/ACompleted
CompareCT.gov

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

ClarVista Medical·interventional·Posted Feb 15, 2017·Updated Jun 22, 2020

In Brief

A clinical study evaluating HARMONI® Modular Intraocular Lens System and Intraoperative optic exchange for Cataract and 2 related conditions. Completed, enrolled 44 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCataract, Corneal Astigmatism, Aphakia
CountriesMexico, Philippines
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 15, 2017
Enrollment StartJun 28, 2016
Primary CompletionJul 18, 2017
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.4 years ago

Interventions

HARMONI® Modular Intraocular Lens Systemdevice

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

Intraoperative optic exchangeprocedure

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