CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 217 enrolled
Drug / intervention
Harmoni Modular Intraocular Lens +2 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/NCT02521766
NCT02521766N/ACompleted
CompareCT.gov

A Prospective, Multi-Center, Feasibility Trial of the ClarVista HARMONI™ Modular Intraocular Lens System for the Treatment of Aphakia Following Cataract Surgery

ClarVista Medical·interventional·Posted Aug 13, 2015·Updated May 14, 2020

In Brief

A clinical study evaluating Harmoni Modular Intraocular Lens, Commercially Available Intraocular Lens, and 1 other intervention for Cataract. Completed, enrolled 217 participants across 2 sites in 2 countries.

Detailed Summary

The main objectives of this feasibility study were: * To demonstrate the feasibility of HARMONI Modular Intraocular Lens (HMIOL) implantation and assembly in subjects undergoing cataract surgery (All HMIOL Cohort), and * To demonstrate the feasibility of the HMIOL optic component exchange procedure (performed 3 months following primary cataract extraction) (Cohort 2).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCataract
CountriesNew Zealand, Philippines
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 13, 2015
Enrollment StartOct 1, 2015
Primary CompletionFeb 7, 2017
Study CompletionOct 26, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.9 years ago

Interventions

Harmoni Modular Intraocular Lensdevice

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

Commercially Available Intraocular Lensdevice

IOL per investigator's standard of care

Optic exchangeprocedure

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