A Comparative Study of Visual Outcome of Two Extended Depth of Focus Intraocular Lenses After Cataract Surgery
Study Details
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 .
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 .
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: The AcrySof™ IQ Vivity™ intraocular lens group The AcrySof™ IQ Vivity™ will be implanted in 20 eyes of 10 patients (group 1) |
Device: IOL implantation
after phacoemulsification of the cataract , implantation of Acrysof IQVIVITY IOL .
Device: IOL implantation
after phacoemulsification of the cataract , implantation of TECNIS Synergy™ Intraocular Lens (Model ZFR00V )
|
| Active Comparator: TECNIS Synergy™ Intraocular Lens (Model ZFR00V ) group The TECNIS Synergy™ Intraocular Lens (Model ZFR00V ) will be implanted in 20 eyes of 10 patients |
Device: IOL implantation
after phacoemulsification of the cataract , implantation of Acrysof IQVIVITY IOL .
Device: IOL implantation
after phacoemulsification of the cataract , implantation of TECNIS Synergy™ Intraocular Lens (Model ZFR00V )
|
Outcome Measures
Primary Outcome Measures
- Range of vision of the different IOLs represented by the defocus curve [within 1 month after surgery]
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 ). [within 1 month after the surgery]
Modulation transfer function under mesopic eye condition and total ocular aberrations will be assessed using ITrace aberrometer
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients undergoing cataract surgery.
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Preoperative corneal astigmatism equal to or less than 0.75 D
Exclusion Criteria:
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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.
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Previous ocular surgeries
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cairo University | Cairo | Egypt | 12613 |
Sponsors and Collaborators
- Cairo University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- MD-43-2022