Intraocular LensNCT05262504
Comparison of a Novel Non-diffractive Extended Depth of Focus Intraocular Lens (IOL) and a Trifocal IOL
An observational study of Intraocular Lens and Cataract, run by Baskent University Ankara Hospital at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraocular Lens, Cataract, Quality of Life
- What is being tested?
- İntraocular lens implantation
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 1 Sep 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 104 eyes of 52 consecutive patients with bilateral cataracts operated between April and September 2021 were included. All patients were interested in spectacle independence. Each participant underwent bilateral sequential cataract surgery and bilateral implantation of a novel non-diffractive EDOF IOL (n=26) or a trifocal IOL (n=26). The patients selected the IOL model after they were fully informed regarding the advantages and disadvantages of each IOL, by their surgeon. Their degree of interest in greater spectacle freedom at far, intermediate, and near distances, as well as their daily activities such as frequency of night driving or reading habits were discussed. The possibility of photic disturbances was described and explained as well.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University Faculty of Medicine
Ankara, 06490
About this study
Official title: Comparison of Visual Performance and Quality of Life With a Novel Non-diffractive Extended Depth-of-focus IOL and a Trifocal IOL
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.
Read the detailed 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).
- Conditions
- Intraocular Lens, Cataract, Quality of Life
- Being tested
- İntraocular lens implantation
- Keywords
- cataract, wavefront shaping, extended depth of focus, trifocal, intraocular lens, quality of life, defocus curve, contrast sensitivity, photic disturbance
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
İntraocular lens implantationDevice
Each participant underwent bilateral sequential cataract surgery and bilateral implantation of a novel non-diffractive EDOF IOL (n=26) or a trifocal IOL (n=26). The interval between the first and second-eye surgeries was 1 to 3 weeks. The patients selected the IOL model after they were fully informed regarding the advantages and disadvantages of each IOL, by their surgeon. Their degree of interest in greater spectacle freedom at far, intermediate, and near distances, as well as their daily activities such as frequency of night driving or reading habits were discussed. The possibility of photic disturbances was described and explained as well.
| Study group | Role | What they receive |
|---|---|---|
| EDOF IOL Group | Patients who were implanted with the novel wavefront shaping extended depth of focus IOL Receives: Device: İntraocular lens implantation | |
| Multifocal IOL group | Patients who were implanted with the multifocal IOL Receives: Device: İntraocular lens implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative visual acuity with or without spectacle correction at near, far and intermediate distances
uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), distance corrected intermediate visual acuity (DCIVA), distance corrected near visual acuity (DCNVA)
Measured: postoperative third month
Defocus-curves
The monocular defocus curves were evaluated under photopic conditions using defocusing lenses from +0.50 D to -4.00 D in 0.50 D steps. The measurements were performed by adding the lenses to the CDVA.
Measured: postoperative third month
Contrast sensitivity
Monocular and binocular contrast sensitivity was assessed with the Pelli-Robson chart under photopic conditions at 3 meters.
Measured: postoperative third month
Reading speed
Reading speed was measured using the validated Turkish version of the MNREAD chart in photopic illumination conditions. It was recorded as number of words read by the patient in one minute (words per minute-wpm).
Measured: postoperative third month
Quality of vision / dysphotopsia
Dysphotopsia was assessed by the Quality of Vision (QoV) questionnaire developed by McAlinden et al. The QoV is a validated Rasch-adjusted questionnaire in which patients are asked to rate specific dysphotopsia items depicted in standard photographs. Patients score each item (0, 1, 2, or 3) in relation to how frequent, severe, and bothersome their symptoms are (30 items in total). Lower QoV scores indicate a better quality of vision.
Measured: postoperative third month
Vision-related quality of life (QOL)
The vision-related QOL was assessed three months after the surgery by the VF-14 QOL questionnaire that was administered face-to-face by a trained researcher (İK). The grading scale was as follows: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Special care was taken not to influence the patients and to ensure that each question was fully understood.
Measured: postoperative third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Apr 2021
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intraocular LensStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University Ankara Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla Asena, Baskent University Ankara Hospital
- Investigators
- Sibel Oto, MD, Study chair, Baskent University Faculty of Medicine Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262504
- Sponsor's protocol ID
- Vivity Panoptix
- Status last verified
- Jul 2023
- First submitted
- 21 Feb 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Data will be available upon request.
Publications
Asena L, Kirci Dogan I, Oto S, Dursun Altinors D. Comparison of visual performance and quality of life with a new nondiffractive EDOF intraocular lens and a trifocal intraocular lens. J Cataract Refract Surg. 2023 May 1;49(5):504-511. doi: 10.1097/j.jcrs.0000000000001142.
PubMed 36700928
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Visual Performance and Quality of Life With a Novel Non-diffractive Extended Depth-of-focus IOL and a Trifocal IOL
- ClinicalTrials.gov ID
- NCT05262504
- Acronym / sponsor ID
- Vivity Panoptix
- Conditions
- Intraocular Lens, Cataract, Quality of Life
- Keywords
- cataract, wavefront shaping, extended depth of focus, trifocal, intraocular lens, quality of life, defocus curve, contrast sensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Baskent University Ankara HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 2 Mar 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 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.
Detailed 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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EDOF IOL Group | – | Device: İntraocular lens implantationPatients who were implanted with the novel wavefront shaping extended depth of focus IOL |
| Multifocal IOL group | – | Device: İntraocular lens implantationPatients who were implanted with the multifocal IOL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 104 eyes of 52 consecutive patients with bilateral cataracts operated between April and September 2021 were included. All patients were interested in spectacle independence. Each participant underwent bilateral sequential cataract surgery and bilateral implantation of a novel non-diffractive EDOF IOL (n=26) or a trifocal IOL (n=26). The patients selected the IOL model after they were fully informed regarding the advantages and disadvantages of each IOL, by their surgeon. Their degree of interest in greater spectacle freedom at far, intermediate, and near distances, as well as their daily activities such as frequency of night driving or reading habits were discussed. The possibility of photic disturbances was described and explained as well.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| İntraocular lens implantationEach participant underwent bilateral sequential cataract surgery and bilateral implantation of a novel non-diffractive EDOF IOL (n=26) or a trifocal IOL (n=26). The interval between the first and second-eye surgeries was 1 to 3 weeks. The patients selected the IOL model after they were fully informed regarding the advantages and disadvantages of each IOL, by their surgeon. Their degree of interest in greater spectacle freedom at far, intermediate, and near distances, as well as their daily activities such as frequency of night driving or reading habits were discussed. The possibility of photic disturbances was described and explained as well. | Device | EDOF IOL Group, Multifocal IOL group |
Primary outcome
Postoperative visual acuity with or without spectacle correction at near, far and intermediate distances
Time frame: postoperative third month
uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), distance corrected intermediate visual acuity (DCIVA), distance corrected near visual acuity (DCNVA)
Defocus-curves
Time frame: postoperative third month
The monocular defocus curves were evaluated under photopic conditions using defocusing lenses from +0.50 D to -4.00 D in 0.50 D steps. The measurements were performed by adding the lenses to the CDVA.
Contrast sensitivity
Time frame: postoperative third month
Monocular and binocular contrast sensitivity was assessed with the Pelli-Robson chart under photopic conditions at 3 meters.
Reading speed
Time frame: postoperative third month
Reading speed was measured using the validated Turkish version of the MNREAD chart in photopic illumination conditions. It was recorded as number of words read by the patient in one minute (words per minute-wpm).
Quality of vision / dysphotopsia
Time frame: postoperative third month
Dysphotopsia was assessed by the Quality of Vision (QoV) questionnaire developed by McAlinden et al. The QoV is a validated Rasch-adjusted questionnaire in which patients are asked to rate specific dysphotopsia items depicted in standard photographs. Patients score each item (0, 1, 2, or 3) in relation to how frequent, severe, and bothersome their symptoms are (30 items in total). Lower QoV scores indicate a better quality of vision.
Vision-related quality of life (QOL)
Time frame: postoperative third month
The vision-related QOL was assessed three months after the surgery by the VF-14 QOL questionnaire that was administered face-to-face by a trained researcher (İK). The grading scale was as follows: 0, no difficulty; 1, a little difficulty; 2, moderate difficulty; 3, quite difficult; 4, impossible to perform. Special care was taken not to influence the patients and to ensure that each question was fully understood.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Derived from this study: PubMed 36700928Asena L, Kirci Dogan I, Oto S, Dursun Altinors D. Comparison of visual performance and quality of life with a new nondiffractive EDOF intraocular lens and a trifocal intraocular lens. J Cataract Refract Surg. 2023 May 1;49(5):504-511. doi: 10.1097/j.jcrs.0000000000001142.
- Individual participant dataSharing planned: Undecided. Data will be available upon request.
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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.
Sibel Oto, MD study chair
Baskent University Faculty of Medicine Department of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraocular Lens and Cataract, run by Baskent University Ankara Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 27 Jul 2023. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative visual acuity with or without spectacle correction at near, far and intermediate distances (time frame: postoperative third month). The study lists 6 primary outcomes in all. 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 NCT05262504, which also lists 1 linked publication.
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 27 Jul 2023.