CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16 enrolled
Drug / intervention
HARMONI® Modular Toric Intraocular Lens +1 moredevice
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Planned bilateral cataract removal by manual phacoemulsification
  • ✓Pre-existing corneal astigmatism 0.75–2.50 diopters in at least one eye
  • ✓Target IOL power 16–26 diopters
  • ✓Stable cornea
Key exclusion· 10
  • ✕History of intraocular or corneal surgery in study eye, including refractive surgery
  • ✕Pregnant or lactating
  • ✕History of clinically significant retinal pathology or ocular diagnosis that could impair visual prognosis
  • ✕Ocular conditions affecting IOL stability

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

Search/NCT03050697
NCT03050697N/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 13, 2017·Updated Jun 12, 2020

In Brief

A clinical study evaluating HARMONI® Modular Toric Intraocular Lens and Cataract extraction with intraocular lens (IOL) implantation for Aphakia and 2 related conditions. Completed, enrolled 16 participants across 1 site.

Detailed Summary

The purpose of this study was to evaluate the safety and effectiveness of the HARMONI® Modular Intraocular Lens System with a toric optic (HMTIOL) in subjects with pre-existing corneal astigmatism in need of cataract surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAphakia, Corneal Astigmatism, Cataract
CountriesNew Zealand
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 13, 2017
Enrollment StartSep 28, 2016
Primary CompletionJun 7, 2017
Study CompletionJul 28, 2017
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.4 years ago

Interventions

HARMONI® Modular Toric Intraocular Lensdevice

Two-component system consisting of a base and a separate toric optic

Cataract extraction with intraocular lens (IOL) implantationprocedure

Cataract removal via manual phacoemulsification, followed by HMTIOL implantation