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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
IOL implantation
IOL implantation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Visual To Compare the Visual Outcome Between AcrySof™ IQ Vivity™ and TECNIS Synergy™ Intraocular Lens (Model ZFR00V )

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

The AcrySof™ IQ Vivity™ intraocular lens group

TECNIS Synergy™ Intraocular Lens (Model ZFR00V ) group

Arm Description

The AcrySof™ IQ Vivity™ will be implanted in 20 eyes of 10 patients (group 1)

The TECNIS Synergy™ Intraocular Lens (Model ZFR00V ) will be implanted in 20 eyes of 10 patients

Outcomes

Primary Outcome Measures

Range of vision of the different IOLs represented by the defocus curve
monocular defocus curve will be obtained by using the best corrected distance refraction and measuring the visual acuity Between +1.50 D and- 2.50 D in 0.5-D defocus steps, except in the region from +0.50 D through* 0.50 D, which would be done in -0.25D steps. Letters will be randomly presented to avoid memorization.

Secondary Outcome Measures

Contrast sensitivity (which will be objectively assessed through modulation transfer function ) - Photic phenomena (which will be objectively expressed through the ocular aberration ).
Modulation transfer function under mesopic eye condition and total ocular aberrations will be assessed using ITrace aberrometer

Full Information

First Posted
November 30, 2022
Last Updated
December 11, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05647421
Brief Title
A Comparative Study of Visual Outcome of Two Extended Depth of Focus Intraocular Lenses After Cataract Surgery
Official Title
A Comparative Study of Visual Outcome of Two Extended Depth of Focus Intraocular Lenses After Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 .
Detailed 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual To Compare the Visual Outcome Between AcrySof™ IQ Vivity™ and TECNIS Synergy™ Intraocular Lens (Model ZFR00V )

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
AcrySof™ IQ Vivity™ and TECNIS Synergy™ Intraocular Lens (Model ZFR00V )
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The AcrySof™ IQ Vivity™ intraocular lens group
Arm Type
Active Comparator
Arm Description
The AcrySof™ IQ Vivity™ will be implanted in 20 eyes of 10 patients (group 1)
Arm Title
TECNIS Synergy™ Intraocular Lens (Model ZFR00V ) group
Arm Type
Active Comparator
Arm Description
The TECNIS Synergy™ Intraocular Lens (Model ZFR00V ) will be implanted in 20 eyes of 10 patients
Intervention Type
Device
Intervention Name(s)
IOL implantation
Intervention Description
after phacoemulsification of the cataract , implantation of Acrysof IQVIVITY IOL .
Intervention Type
Device
Intervention Name(s)
IOL implantation
Intervention Description
after phacoemulsification of the cataract , implantation of TECNIS Synergy™ Intraocular Lens (Model ZFR00V )
Primary Outcome Measure Information:
Title
Range of vision of the different IOLs represented by the defocus curve
Description
monocular defocus curve will be obtained by using the best corrected distance refraction and measuring the visual acuity Between +1.50 D and- 2.50 D in 0.5-D defocus steps, except in the region from +0.50 D through* 0.50 D, which would be done in -0.25D steps. Letters will be randomly presented to avoid memorization.
Time Frame
within 1 month after surgery
Secondary Outcome Measure Information:
Title
Contrast sensitivity (which will be objectively assessed through modulation transfer function ) - Photic phenomena (which will be objectively expressed through the ocular aberration ).
Description
Modulation transfer function under mesopic eye condition and total ocular aberrations will be assessed using ITrace aberrometer
Time Frame
within 1 month after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
alaa mohamed badawy, MSC
Phone
01008858267
Email
alaabadawy93@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed hosny, MD
Phone
01000007675
Email
mohamedhosny@mac.com
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
12613
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32511121
Citation
Kanclerz P, Toto F, Grzybowski A, Alio JL. Extended Depth-of-Field Intraocular Lenses: An Update. Asia Pac J Ophthalmol (Phila). 2020 May-Jun;9(3):194-202. doi: 10.1097/APO.0000000000000296.
Results Reference
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PubMed Identifier
27943250
Citation
de Silva SR, Evans JR, Kirthi V, Ziaei M, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev. 2016 Dec 12;12(12):CD003169. doi: 10.1002/14651858.CD003169.pub4.
Results Reference
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PubMed Identifier
32932369
Citation
Auffarth GU, Gerl M, Tsai L, Janakiraman DP, Jackson B, Alarcon A, Dick HB; Quantum Study Group. Clinical evaluation of a new monofocal IOL with enhanced intermediate function in patients with cataract. J Cataract Refract Surg. 2021 Feb 1;47(2):184-191. doi: 10.1097/j.jcrs.0000000000000399.
Results Reference
background
PubMed Identifier
28923587
Citation
Kohnen T, Herzog M, Hemkeppler E, Schonbrunn S, De Lorenzo N, Petermann K, Bohm M. Visual Performance of a Quadrifocal (Trifocal) Intraocular Lens Following Removal of the Crystalline Lens. Am J Ophthalmol. 2017 Dec;184:52-62. doi: 10.1016/j.ajo.2017.09.016. Epub 2017 Sep 18.
Results Reference
background
PubMed Identifier
25884715
Citation
Carballo-Alvarez J, Vazquez-Molini JM, Sanz-Fernandez JC, Garcia-Bella J, Polo V, Garcia-Feijoo J, Martinez-de-la-Casa JM. Visual outcomes after bilateral trifocal diffractive intraocular lens implantation. BMC Ophthalmol. 2015 Mar 14;15:26. doi: 10.1186/s12886-015-0012-4.
Results Reference
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A Comparative Study of Visual Outcome of Two Extended Depth of Focus Intraocular Lenses After Cataract Surgery

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