NCT04865016

Low Add Multifocal Versus Extended Depth of Focus Intraocular Lens

Completed NA Last updated 29 April 2021

What this trial tests

NA trial testing Tecnis +2.75 D (ZKB00) and Tecnis Symfony (ZXR00) in Multifocal Intraocular Lenses in 29 participants. Completed in 1 March 2019.

Timeline

1 October 2016

Primary endpoint
1 September 2018

1 March 2019

Quick facts

Lead sponsor	Marmara University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	29
Start date	1 October 2016
Primary completion	1 September 2018
Estimated completion	1 March 2019
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Tecnis +2.75 D (ZKB00) and Tecnis Symfony (ZXR00)

Conditions studied

• Multifocal Intraocular Lenses — all drugs for Multifocal Intraocular Lenses →
• Extended Depth of Focus — all drugs for Extended Depth of Focus →

Sponsor

Marmara University

Who can join

18 and older, any sex, with Multifocal Intraocular Lenses or Extended Depth of Focus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The innovations in phacoemulsification surgery and advances in surgical equipment ensure a safe extraction of the crystalline lens and implantation of intraocular lenses (IOL). As a result of developing intraocular lens technologies and changing patient demands, many multifocal, accommodative, toric, toric-multifocal, and extended depth of focus (EDOF) IOLs have been introduced and the original aim of restoration of far vision with implanted monocular IOLs has been evolved to an objective of improved vision at different distances with total spectacle independence. This study aimed to compare the visual acuity at different distances, contrast sensitivity, spectacle needs, photic phenomena, and quality of life parameters of patients bilaterally implanted with a low add bifocal (Tecnis ZKB00) or an EDOF IOL (Tecnis Symfony), both with planned mini-monovision to improve near vision.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Trifocal versus extended depth of focus (EDOF) intraocular lenses after cataract extraction.
   Tavassoli S, Ziaei H, Yadegarfar ME, Gokul A, et al · · 2024 · cited 21× · PMID 38984608 · DOI 10.1002/14651858.cd014891.pub2
2. Clinical outcomes with a low add multifocal and an extended depth of focus intraocular lenses both implanted with mini-monovision.
   Sevik MO, Akkaya Turhan S, Toker E. · · 2022 · cited 16× · PMID 34117383 · DOI 10.1038/s41433-021-01600-3