Visual To Compare the Visual Outcome Between AcrySof™ IQ Vivity™ and TECNIS Synergy™ Intraocular Lens (Model ZFR00V )NCT05647421
A Comparative Study of Visual Outcome of Two Extended Depth of Focus Intraocular Lenses After Cataract Surgery
A study testing IOL implantation in people with Visual To Compare the Visual Outcome Between AcrySof™ IQ Vivity™ and TECNIS Synergy™ Intraocular Lens (Model ZFR00V ), run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual To Compare the Visual Outcome Between AcrySof™ IQ Vivity™ and TECNIS Synergy™ Intraocular Lens (Model ZFR00V )
- What is being tested?
- IOL implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing cataract surgery.
- Preoperative corneal astigmatism equal to or less than 0.75 D
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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 .
Read the 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 .
- Being tested
- IOL implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOL implantationDevice
after phacoemulsification of the cataract , implantation of Acrysof IQVIVITY IOL .
IOL implantationDevice
after phacoemulsification of the cataract , implantation of TECNIS Synergy™ Intraocular Lens (Model ZFR00V )
| Study group | Role | What they receive |
|---|---|---|
| The AcrySof™ IQ Vivity™ intraocular lens group | Active comparator | The AcrySof™ IQ Vivity™ will be implanted in 20 eyes of 10 patients (group 1) Receives: Device: IOL implantation |
| TECNIS Synergy™ Intraocular Lens (Model ZFR00V ) group | Active comparator | The TECNIS Synergy™ Intraocular Lens (Model ZFR00V ) will be implanted in 20 eyes of 10 patients Receives: Device: IOL implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 1 month after surgery
Secondary outcomes (1)
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
Measured: within 1 month after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Jan 2022
- Primary completionMar 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Visual To Compare the Visual Outcome Between AcrySof™ IQ Vivity™ and TECNIS Synergy™ Intraocular Lens (Model ZFR00V )Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- AcrySof™ IQ Vivity™ and TECNIS Synergy™ Intraocular Lens (Model ZFR00V )
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mohamed Badawy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647421
- Sponsor's protocol ID
- MD-43-2022
- Status last verified
- Dec 2022
- First submitted
- 30 Nov 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32511121de 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.
PubMed 27943250Auffarth 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.
PubMed 32932369Kohnen 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.
PubMed 28923587Carballo-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.
PubMed 25884715
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Visual Outcome of Two Extended Depth of Focus Intraocular Lenses After Cataract Surgery
- ClinicalTrials.gov ID
- NCT05647421
- Acronym / sponsor ID
- MD-43-2022
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- AcrySof™ IQ Vivity™ and TECNIS Synergy™ Intraocular Lens (Model ZFR00V )
| Arm | Type | Receives |
|---|---|---|
| The AcrySof™ IQ Vivity™ intraocular lens group | Active comparator | Device: IOL implantationThe AcrySof™ IQ Vivity™ will be implanted in 20 eyes of 10 patients (group 1) |
| TECNIS Synergy™ Intraocular Lens (Model ZFR00V ) group | Active comparator | Device: IOL implantationThe TECNIS Synergy™ Intraocular Lens (Model ZFR00V ) will be implanted in 20 eyes of 10 patients |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing cataract surgery.
- Preoperative corneal astigmatism equal to or less than 0.75 D
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IOL implantationafter phacoemulsification of the cataract , implantation of Acrysof IQVIVITY IOL . | Device | TECNIS Synergy™ Intraocular Lens (Model ZFR00V ) group, The AcrySof™ IQ Vivity™ intraocular lens group |
| IOL implantationafter phacoemulsification of the cataract , implantation of TECNIS Synergy™ Intraocular Lens (Model ZFR00V ) | Device | TECNIS Synergy™ Intraocular Lens (Model ZFR00V ) group, The AcrySof™ IQ Vivity™ intraocular lens group |
Primary outcome
Range of vision of the different IOLs represented by the defocus curve
Time frame: 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.
1 secondary outcome
Contrast sensitivity (which will be objectively assessed through modulation transfer function ) - Photic phenomena (which will be objectively expressed through the ocular aberration ).
Time frame: within 1 month after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Background: PubMed 32511121Kanclerz 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.
- Background: PubMed 27943250de 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.
- Background: PubMed 32932369Auffarth 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.
- Background: PubMed 28923587Kohnen 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.
- Background: PubMed 25884715Carballo-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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IOL implantation in people with Visual To Compare the Visual Outcome Between AcrySof™ IQ Vivity™ and TECNIS Synergy™ Intraocular Lens (Model ZFR00V ), run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact alaa mohamed badawy, MSC (01008858267, alaabadawy93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of vision of the different IOLs represented by the defocus curve (time frame: within 1 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05647421, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022.