NCT04865016

Low Add Multifocal Versus Extended Depth of Focus Intraocular Lens

Clinical Outcomes With a Low Add Multifocal and an Extended Depth of Focus Intraocular Lenses Both Implanted With Mini-monovision

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Marmara University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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. In this regard, binocular logMAR uncorrected visual acuities (UVA), monocular defocus curves, CS with CSV 1000-E and Pelli-Robson Test (PRT), spectacle needs and quality of life parameters with NEI RQL-42 questionnaire were evaluated at postoperative 1, 3, and 6 months.

Conditions

• Multifocal Intraocular Lenses
• Extended Depth of Focus

Interventions

Type	Name	Description
DEVICE	Tecnis +2.75 D (ZKB00) and Tecnis Symfony (ZXR00)	This study included 30 eyes of 15 cataract patients undergoing cataract surgery with implantation of a low add (+2.75 Diopters \[D\]) bifocal (Tecnis ZKB00; Johnson and Johnson Surgical Vision Inc., Jacksonville, Florida, USA) IOL (MIOL Group) and 30 eyes of 15 patients with implantation of an EDOF (Tecnis Symfony \[ZXR00\]; Johnson and Johnson Surgical Vision Inc., Jacksonville, Florida, USA) IOL (EDOF Group).

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-09-01
• Completion: 2019-03-01
• First posted: 2021-04-29
• Last updated: 2021-04-29

Locations

1 site across 1 country: Turkey (Türkiye)