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A Comparative Study of Visual Outcome of Two Extended Depth of Focus Intraocular Lenses After Cataract Surgery

Cairo University (CU) logo

Cairo University (CU)

Status

Enrolling

Conditions

Visual To Compare the Visual Outcome Between AcrySof™ IQ Vivity™ and TECNIS Synergy™ Intraocular Lens (Model ZFR00V )

Treatments

Device: IOL implantation

Study type

Interventional

Funder types

Other

Identifiers

NCT05647421
MD-43-2022

Details and patient eligibility

About

The investigators aim to compare the visual performance of the most recently introduced extended depth of focus intraocular lenses ; AcrySofTM IQ VivityTM and TECNIS SynergyTM ( an extended depth of focus IOL ) regarding the range of vision (using defocus curve ) , contrast sensitivity( through the modulation transfer function curves ) and their effect on ocular aberrations as the ivestigators believe that proper study of these aspects could influence the investigators choice and guidance to the cataract patient about the most suitable presbyopia correcting IOL .

Full description

Presbyopia-correcting IOLs can be divided into 4 broad categories: Enhanced monofocal IOLs , Mutifocal IOLs (including diffractive or refractive designs) , extended depth-of-focus (EDOF) IOLs, and accommodative IOLs .

Standard multifocal lenses ( e.g : FineVision® (Physiol, Liège, Belgium) are diffractive IOLs which split incident light into two or more points of focus, but these lenses are limited by the optical aberrations and the presence of secondary out-of-focus image and photic phenomena .

The new Tecnis® EyhanceIOL (model ICB00, Johnson & Johnson Vision, Santa Ana, CA, USA) is a refractive modified monofocal lens with better intermediate visual acuity than standard monofocal IOLs and eliminates the dysphotopsia that is common with the standard multifocal IOLs and compensates for the spherical aberration of the cornea due to its high order aspheric profile .

The EDOF IOL, or extended range of vision IOL, incorporates a new technology which createsa single-elongated focal point to enhance the depth-of-focus, contrary to monofocal IOLs (in which light is focused on one single point) or MF IOLs (having 2 or 3 discrete points). This elongated focus is introduced to eliminate the overlapping of near and far images caused by traditional MF IOLs, thus eliminating the halo effect .However , EDOF IOLs are thought to be inferior to standard trifocal IOls regarding near vision.

AcrySof™ IQ Vivity™ Extended Vision Intraocular Lens (Alcon, Fort Worth, Texas,USA ) was approved by the Food and Drug Administration in February 2020 and it is considered the most recently introduced non-diffractive EDOF IOL . TECNIS Synergy™ Intraocular Lens (Model ZFR00V) (Johnson & Johnson Vision,SantaAna, CA, USA) is a continuous depth of focus intraocular lens and was approved by food and drug administration in April 2021 . it combines both elements of standard multifocal and extended depth of focus with preservation of high contrast sensitivity .

The investigators aim to compare the visual performance of the most recently introduced extended depth of focus intraocular lengths ; AcrySof™ IQ Vivity™ and TECNIS Synergy™ ( an extended depth of focus IOL ) regarding the range of vision (using defocus curve ) , contrast sensitivity( through the modulation transfer function curves ) and their effect on ocular aberrations as the investigators believe that proper study of these aspects could influence the ophthalmologists' choice and guidance to the cataract patient about the most suitable presbyopia correcting IOL .

Enrollment

40 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients undergoing cataract surgery.
  • Preoperative corneal astigmatism equal to or less than 0.75 D

Exclusion criteria

  • Other ocular comorbidities which may affect the outcome of our research such as glaucoma, corneal opacities , chronic or recurrent anterior uveitis, diabetic retinopathy , age -related macular degeneration.
  • Previous ocular surgeries

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

The AcrySof™ IQ Vivity™ intraocular lens group
Active Comparator group
Description:
The AcrySof™ IQ Vivity™ will be implanted in 20 eyes of 10 patients (group 1)
Treatment:
Device: IOL implantation
Device: IOL implantation
TECNIS Synergy™ Intraocular Lens (Model ZFR00V ) group
Active Comparator group
Description:
The TECNIS Synergy™ Intraocular Lens (Model ZFR00V ) will be implanted in 20 eyes of 10 patients
Treatment:
Device: IOL implantation
Device: IOL implantation

Trial contacts and locations

1

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Central trial contact

mohamed hosny, MD; alaa mohamed badawy, MSC

Data sourced from clinicaltrials.gov

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