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Comparison of a Novel Non-diffractive Extended Depth of Focus Intraocular Lens (IOL) and a Trifocal IOL

B

Baskent University Ankara Hospital

Status

Completed

Conditions

Cataract
Quality of Life
Intraocular Lens

Treatments

Device: İntraocular lens implantation

Study type

Observational

Funder types

Other

Identifiers

NCT05262504
Vivity Panoptix

Details and patient eligibility

About

The purpose of this study is to compare visual performance and quality of life (QOL) following bilateral implantation of a novel non-diffractive extended depth-of-focus (EDOF) intraocular lens (IOL) (AcrySof® IQ Vivity, Alcon, TX, USA) and a trifocal IOL (Acrysof® IQ PanOptix, Alcon, Fort Worth, TX) in a prospective comparative interventional case series.

Full description

Developments in cataract surgical devices and intraocular lenses (IOL) increased patient expectations and changed the practice patterns in ophthalmology. Nowadays, cataract surgery is considered as a refractive surgery. With multifocal IOLs, spectacle independence can be achieved with a good distance, intermediate and near visual acuity. This is associated with increased quality of life after cataract surgery.The most important disadvantages of multifocal IOLs are loss of contrast sensitivity and photic phenomena such as glare and halo. Although multifocal IOLs are more frequently associated with photic disturbances than monofocal IOLs, the trifocal IOLs have improved performance in photic phenomena when compared to bifocal IOLs. Recently, a new technology known as extended depth of focus (EDOF) IOLs have been developed. These lenses create a single elongated focal point to enhance the depth of focus, improving intermediate vision without compromising distance vision. Although EDOF IOLs provide better intermediate distance vision when compared to monofocal IOLs, near vision is not as good as trifocal IOLs. The most important advantage provided by the EDOF technology is lower rate of photic disturbances than trifocal IOL designs. The aim of this study was to compare the visual performance and patient-reported quality of life (QOL) outcomes following bilateral implantation of a novel non-diffractive wavefront shaping EDOF IOL (AcrySof® IQ Vivity, Alcon Research, TX, USA) and a trifocal IOL (AcrySof® IQ PanOptix, Alcon Laboratories, Fort Worth, TX).

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Cataract patients scheduled for surgery who are interested in spectacle independence.
  • Bilateral cataract with plan of bilateral sequential cataract surgery.
  • Adult patients older than 18 years of age
  • Normal cognitive function, able to understand advantages and disadvantages associated with different types of IOLs.

Exclusion criteria

  • Ocular diseases other than cataract including irregular astigmatism, diabetic retinopathy, age-related macular degeneration or any other retinal diseases, severe dry eye, glaucoma, amblyopia, uveitis, pseudoexfoliation syndrome, abnormal pupillary function, history of intraocular or corneal surgery, congenital eye abnormalities, or eye trauma.
  • Patients with high myopia with axial length (AL) ≥ 26,5 mm and high hyperopia (AL ≤ 21.5 mm)
  • Lifestyle and work-related factors requiring sharp near or distance vision
  • Patients with unrealistic visual expectations.

Trial design

52 participants in 2 patient groups

EDOF IOL Group
Description:
Patients who were implanted with the novel wavefront shaping extended depth of focus IOL
Treatment:
Device: İntraocular lens implantation
Multifocal IOL group
Description:
Patients who were implanted with the multifocal IOL
Treatment:
Device: İntraocular lens implantation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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