NCT03771274

Tecnis ZLB00 & Symfony Intraocular Lens Combination Outcomes

Visual Outcomes of an Extended Depth of Focus (EDOF) Intraocular Lens (IOL) Combined With a Multifocal (MF) IOL

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Carolina Eyecare Physicians, LLC · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Current visual outcomes expectations of cataract patients are similar to those of refractive surgery patients. Their desire is to be spectacle independent for far, intermediate and near vision activities. Some may have already enjoyed freedom from glasses and would like to continue after the cataracts are removed. Different options are available. These options include: mono-vision and presbyopia correcting intraocular lenses (IOL). Presbyopia correcting IOLs include accommodative, multifocals and extended depth of focus (EDOF) IOLs. In a previous study, the visual outcomes of the EDOF Toric IOL were evaluated when both eyes were targeted for plano and when the non-dominant eye was set for a small residual myopic error (-0.50 D) or nanovision in patients with astigmatism. The nanovision approach, appeared to provide similar binocular acuity at distance and intermediate but better acuity at near. The purpose of this study is to evaluate the visual outcomes of an EDOF IOL when combined with a multifocal IOL with a +3.25 D add in patients with or without astigmatism undergoing routine cataract surgery.

Conditions

• Cataract Bilateral
• Presbyopia

Interventions

Type	Name	Description
DEVICE	Tecnis ZLB00 & Symfony IOL	The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye.

Timeline

• Start date: 2018-12-07
• Primary completion: 2019-10-31
• Completion: 2019-10-31
• First posted: 2018-12-11
• Last updated: 2020-08-10
• Results posted: 2020-08-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study