NCT03082599

Symfony Toric Intraocular Lens Visual Outcomes

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Carolina Eyecare Physicians, LLC · Academic / Other
• Sex: All
• Age: 40 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cataract Bilateral
• Astigmatism Bilateral

Interventions

Type	Name	Description
DEVICE	Presbyopia and astigmatism correcting intraocular lens	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.

Timeline

• Start date: 2017-02-17
• Primary completion: 2018-04-03
• Completion: 2018-04-03
• First posted: 2017-03-17
• Last updated: 2020-01-27
• Results posted: 2020-01-27

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study