NCT03997890

Clinical Outcomes of Patients Bilaterally Implanted With the TECNIS® Symfony or TECNIS® Symfony Toric Extended Range of Vision IOL

Completed NA Last updated 27 June 2019

What this trial tests

NA trial testing Cataract surgery with binocular implantation of either Symfony (ZXR00) or Symfony toric (ZXT) IOLs in Cataract in 96 participants. Completed in 18 January 2018.

Timeline

13 July 2016

Primary endpoint
18 January 2018

18 January 2018

Quick facts

Lead sponsor	Yonsei University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	96
Start date	13 July 2016
Primary completion	18 January 2018
Estimated completion	18 January 2018
Sites	1 location across South Korea

Drugs / interventions tested

• Cataract surgery with binocular implantation of either Symfony (ZXR00) or Symfony toric (ZXT) IOLs

Conditions studied

• Cataract — all drugs for Cataract →

Sponsor

Yonsei University

Who can join

Adults 20 to 85, any sex, with Cataract. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In With increased patients' demand for a spectacle-free lifestyle and technological advancements, cataract surgery with multifocal intraocular lens (IOL) implantation has become an effective solution for correcting presbyopia in patients who want to maintain their full range of vision.

Conventional bifocal IOLs used either refractive or diffractive optics to split the light and create 2 principal focal points, thus providing functional vision at distance and near. This simultaneous imaging principle produces a sharp image that is overlaid by a secondary blurred out-of focus image, so these IOLs inherently produce a deterioration in contrast sensitivity and unwanted photic phenomena such as glare and halos. Additionally, studies reported insufficient intermediate vision with bifocal IOLs.

There is an increasing desire for spectacle independence at intermediate distance, especially due to the increased use of computers and smartphones. Trifocal IOLs were introduced to the market in 2010 and participants provide an additional, third focal point to improve intermediate vision without compromising distance and near vision. However, participants are still vulnerable to decreased contrast sensitivity and photic phenomena due to the IOL's mechanism of splitting the light into discrete focal points.

An extended depth of focus (EDOF) technology was recently introduced with the aim to improve intermediate vision while maintaining image contrast. The diffractive echelette design, embedded on its posterior optical surface, extends the range of vision and the achromatic technology reduces corneal chromatic aberrations to enhance retinal image quality and improve contrast sensitivity. The elongated focus allows imaging in a continuous range of vision without overlapping near and far images, and therefore theoretically would provide a more consistent distance and intermediate vision with less dysphotopsia.

The aim of this study was to investigate the clinical outcome of patients bilaterally implanted with either Tecnis Symfony or Tecnis Symfony toric extended range of vision IOLs (Johnson \& Johnson Vision, Santa Ana, CA, USA) in terms of visual performance at different distances, spectacle independence, photic phenomena, and patient satisfaction.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Visual Outcomes after Bilateral Implantation of an Extended Depth of Focus Intraocular Lens: A Multicenter Study.
   Choi M, Im CY, Lee JK, Kim HI, et al · · 2020 · cited 11× · PMID 33307603 · DOI 10.3341/kjo.2020.0042