CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
Presbyopia and astigmatism correcting intraocular lensdevice
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/NCT03082599
NCT03082599N/ACompleted

Visual Outcomes of an Extended Depth of Focus (EDOF) Intraocular Lens (IOL)

Carolina Eyecare Physicians, LLC·interventional·Posted Mar 17, 2017·Updated Jan 27, 2020

In Brief

A clinical study evaluating Presbyopia and astigmatism correcting intraocular lens for Cataract Bilateral and Astigmatism Bilateral. Completed, enrolled 120 participants across 4 sites.

Detailed Summary

In July 2016, the FDA approved an extended depth of focus (EDOF) IOL (Tecnis Symfony, Abbott Medical Optics) helping to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery. It is available in both a non-toric version and a toric version for patients with astigmatism. The difference between this lens and the multifocal (MIOL) counterpart is that the EDOF, similarly to a monofocal IOL, has one focal point (elongated in the EDOF) while the multifocals have 2 focal points; therefore, having less of a halo and glare problem. Pivotal trial results where Symfony was compared to a monofocal IOL showed similar uncorrected distance visual acuity (UCDVA), better intermediate (77% vs. 34% 20/25 uncorrected intermediate visual acuity - UCIVA) and near vision (Symfony patients were able to read two additional, progressively smaller lines compared to the monofocal IOL).A One potential disadvantage of the EDOF IOL compared to a MIOL is the visual performance at near.B One option to deal with this potential shortcoming is to set the non-dominant eye for a small residual myopic error (-0.50 D)C what is referred to as nano-vision or mini mono-vision.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 17, 2017
Enrollment StartFeb 17, 2017
Primary CompletionApr 3, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.3 years ago

Interventions

Presbyopia and astigmatism correcting intraocular lensdevice

The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.