Evaluation of Visual Function After Bilateral Implantation of EDOF IOLs (Vario-NL)
Primary Purpose
Cataract Bilateral, Lens, Intraocular, Lens Implantation, Intraocular
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Acunex Vario intraocular lens
Alcon AcrySof IQ Vivity intraocular lens
Sponsored by
About this trial
This is an interventional treatment trial for Cataract Bilateral focused on measuring Extended depth of Focus intraocular lenses, Intermermediate visual acuity
Eligibility Criteria
Inclusion Criteria:
- Minimum 18 years of age
- Bilateral cataract
- Bilateral implantation of either Acunex® Vario IOL or the Alcon AcrySof® IQ Vivity® IOL
- Expected postoperative astigmatism ≤ 1.00 D (use of femtosecond laser assisted cataract surgery (FLACS) AK's tolerated up to 1.5 D of corneal astigmatism preoperative)
- Bilateral implantation of a non-toric Acunex® Vario IOL or a non-toric Alcon AcrySof® IQ Vivity® IOL
- IOL power calculation between +10.00 D and +30.0 D
- Expected postoperative best-corrected visual acuity of logMAR 0.3 or better
- Availability to undergo second eye surgery on the same day or else within 2 weeks of the first eye surgery
- Willing and able to comply with scheduled visits and other study procedures
- Signed informed consent
Exclusion Criteria:
- Previous corneal surgery and/or reshaping
- Corneal pathology (i.e., fuchs endothelial dystrophy (FED), irregular astigmatism, herpes simplex virus (HSV) keratitis
- Extensive age-related macular degeneration (atrophic or exudative age-related macular degeneration or numerous soft drusen) and post-intravitreal injection (IVI)
- Extensive visual field loss (eg. glaucoma, cerebral vascular accident (CVA), hemianopsia, etc.)
- Extensive diabetic retinopathy
- Amblyopia, strabismus, diplopia
- Pseudo exfoliation syndrome or other capsule or zonular abnormalities that could affect postoperative centration or tilt of the IOL
- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic /scotopic conditions)
- Cognitive cerebral or concentration disorders (e.g., dementia, Parkinson, stroke, etc.)
- Suturing of incision required at time of surgery
- Complications during surgery of the first eye.
Sites / Locations
- Maastricht UMC+
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vario-group
Vivity-group
Arm Description
Patients in this group recieve the Acunex Vario IOL bilaterally during the cataract surgery.
Patients in this group recieve the Alcon Acrysof IQ Vivity IOL bilaterally during the cataract surgery.
Outcomes
Primary Outcome Measures
Binocular uncorrected intermediate visual acuity
The visual acuity will be measured at 66cm under photopic conditions
Secondary Outcome Measures
Mono- and binocular uncorrected and corrected distance visual acuity
The visual acuities will be measured at 4 meters under photopic conditions
Mean binocular distance-corrected intermediate visual acuity
The visual acuity will be measured at 66cm under photopic conditions
Mean binocular uncorrected near visual acuity and distaqnce corrected near visual acuity
The visual acuity will be measured at 40cm under photopic conditions
Binocular defocus curves
Under photopic conditions
Mean binocular constrast sensitivity
Under photopic and mesopic conditions
Complication profile including halos and glare
According to the 4-point likert scale (ranging from 'no' to 'very disturbing')
Questionnaires on patient satisfaction rate
Using questionnaire: Catquest-NL, including different questions and answer options of satisfaction rate (4-point scale ranging from 'very dissatisfied' to 'very satisfied')
Questionnaires on patient difficulty rate
Using questionnaire: Catquest-NL, including different questions and answer options of difficulties (4-point scale ranging from 'Very big difficulties' to 'no difficulties').
Questionnaires on occurence of optical complaints
Using questionnaires: QoV-NL, including different questions and answer options about how often the complaints happen (4-point scale ranging from 'never' to 'very often').
Questionnaires on the bothersome of optical complaints
Using questionnaires: QoV-NL, including different questions and answer options about how bothersome it is for the patient (4-point scale ranging from 'Not at all' to 'Very').
Questionnaires on spectacle independence
Using questionnaires: IOLSAT, including different questions and 5-point scale answer options ranging from 0 (Never) to 4 (Always)
Tilt and decentration intraocular lens
Using Optical Coherence Tomography scans
Full Information
NCT ID
NCT05335408
First Posted
March 31, 2022
Last Updated
October 18, 2023
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05335408
Brief Title
Evaluation of Visual Function After Bilateral Implantation of EDOF IOLs
Acronym
Vario-NL
Official Title
A Randomized Controlled Trial on the Visual Function After Bilateral Implantation of Two Novel Extended Depth-of-Focus Intraocular Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 2, 2022 (Actual)
Primary Completion Date
June 9, 2023 (Actual)
Study Completion Date
June 9, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Since intermediate vision is becoming increasingly important in our day-to-day tasks, a new IOL was introduced (Acunex Vario) with this objective in mind. This IOL provides excellent vision at far and intermediate distances up to 60 cm and with negligible photopic disturbances compared to conventional multifocal lenses. The Alcon AcrySof IQ Vivity IOL is designed to provide continuous vision from distance to intermediate while preserving contrast sensitivity and with a monofocal visual disturbance profile. So far, there are no published studies comparing these new IOL designs that offer an extended range of vision at far and intermediate distances.
Objective: The primary objective of this study is to compare the binocular uncorrected intermediate visual acuity (UIVA) at 66 cm under photopic conditions 3 months postoperatively, in a series of patients bilaterally implanted with the Vario IOL versus those bilaterally implanted with the Vivity IOL.
Study design: controlled double masked, randomized, prospective clinical trial Study population: patients of 18 years or older with bilateral cataracts that require cataract surgery.
Intervention: One group receives bilateral implantation with the Vario IOL and the other group receives bilateral implantation with the Vivity IOL.
Main study parameters: The main study parameter is the binocular UIVA at 66 cm under photopic conditions at 3 months postoperatively.
Hypothesis: The investigators hypothesise that bilateral implantation with the Vario IOL is non-inferior when compared to bilateral implantation with the Vivity IOL, with regards to binocular UIVA at 66 cm under photopic conditions 3 months postoperatively.
Cataract extraction in this study will proceed according to regular cataract surgery. As with any type of intraocular surgery, there is a possibility of complications due to anesthesia, drug reactions, and surgical problems. Postoperatively, there will be one extra postoperative visit, compared to standard cataract surgery follow-up. Spectacle-independency postoperatively, without photopic phenomena, is one of the major expected benefits when treating cataract (and presbyopia) with the implantation of the Vario or Vivity IOLs.
Detailed Description
INTRODUCTION AND RATIONALE
Nowadays, the most common types of intraocular lenses (IOLs) to correct aphakia after cataract surgery consist of monofocal, multifocal or extended depth of focus (EDOF) IOLs.
Current monofocal IOLs provide one focal point which will provide the patient with unaided vision at only one distance, which necessitate the need of glasses to correct vision at all other distances.
Multifocal IOLs (mIOLs) can be divided into bifocal-, trifocal- or quadrifocal IOLs, and provide patients with unaided vision at more than one distance, causing less spectacle-dependency after cataract surgery. Although mIOLs offer better unaided near vision and less spectacle dependency in comparison to monofocal IOLs, a well-known drawback of mIOLs is the occurrence of halos and glare and the inherent loss of contrast sensitivity because of their optical design. The potential decrease in quality of vision makes implantation of mIOLs less suitable in highly demanding patients or in cases of pre-existing pathology of the visual pathway (i.e., macular degeneration, optic neuropathy, post refractive surgery).
EDOF IOLs offer an extended range of focus and enable the patient to have a wider range of unaided vision in comparison to monofocal IOLs, especially from intermediate to far, while mIOLs have shown better near vision in comparison to EDOF IOLs.
Photic phenomena like halos and glare are regarded as the most important drawbacks of mIOLs and EDOF lenses. These photic phenomena can be explained due to the optical design where either diffractive or zonal refractive technology is applied. These photic phenomena become less apparent in a few months after neuroadaptation has taken place in the majority of cases. However, these phenomena can persist in some patients and are one of the main reasons for IOL explantation.
Since intermediate vision is becoming increasingly important in day-to-day tasks due to smartphone, tablet and laptop use, a new IOL was introduced with this objective in mind. The extended depth of focus IOL provides vision at far and intermediate distances up to 60 cm. Both the Acunex® Vario and the Alcon AcrySof® IQ Vivity® IOL consist of this EDOF optic design. The Acunex® Vario IOL design includes a sector-shaped near vision +1.5D addition located on the anterior surface of the IOL. The Alcon AcrySof® IQ Vivity® IOL consists of two anterior surface transition elements: the surface transition element, which includes a slightly elevated plateau for stretching the wavefront, and a small curvature change for shifting the wavefront. The last mentioned wavefront-shaping area stretches and shifts the wavefront resulting in an extended focal range of >1.5 D.
The Alcon AcrySof® IQ Vivity® IOL is a commonly used EDOF IOL and has been used for several years offering good visual outcomes in patients. Patients who received this IOL in the Maastricht University Medical Center+ (MUMC+) are satisfied with their vision quality and rarely complain about dysphotopsias after implantation. The Acunex® Vario IOL is a new EDOF IOL. According to prior preliminary results and pilot studies, this IOL demonstrates good results, including excellent distance and intermediate visual acuity, very low levels of dysphotopsia and high levels of postoperative patients satisfaction.
Both IOLs offer extended depth of focus and have similar results according to our own experience and prior research, but there are no published studies comparing these IOLs in a randomized controlled trial. The aim of this study is to compare the optical function, side effects and patient satisfaction after implantation of the Acunex® Vario and Alcon Acrysof® IQ Vivity® IOL in a controlled double masked, randomized, prospective clinical trial.
STUDY DESIGN
Patients will be examined pre-operatively and 1 week, and 1 and 3 months postoperatively. Besides a preoperative visit at which both eyes are examined, 4 postoperative visits are included when delayed sequential bilateral cataract surgery (DSBCS) is performed: week 1 visit for the first operated eye, week 1 visit for the second operated eye, and 1-, and 3-months visits at which both eyes will be examined in the same visit. In the event that immediately sequential bilateral cataract surgery (ISBCS) is performed the week 1 visit will be combined resulting in 3 postoperative visits. In both scenario's (ISBCS or DSBCS) both eyes are examined simultaneously at 1, and 3 months postoperatively in order to minimize the number of postoperative follow-up visits for patients. Consequently, with DSBCS, at 1 months postoperatively, the first eye will be 5 weeks after surgery and the second eye 3 weeks. At 3 months postoperatively, the first eye will be 13 weeks after surgery and the second eye 11 weeks. The investigators assume that this time difference does not affect the results. At the control visits, patients will receive a general ophthalmic examination, imaging of the eye and will be asked to fill-in patient questionnaires.
The duration of the study is 18 months, based on preparation of the study in the first 3 months, the inclusion of patients into the Randomized Controlled Trial (RCT) in the following 9 months, a follow-up of 3 months after IOL implantation and analysis of the data during the last 3 months of the study.
STATISTICAL ANALYSIS
All data will be collected in Castor, an electronic data capture (EDC) system designed for medical research, and exported to SPSS (IBM Corp., USA) and/or Excel (Microsoft, USA) software packages for data analysis. For the final analysis of the data, a per-protocol analysis is used. For the analysis, only patients who have completed the originally allocated treatment (i.e. bilateral implantation of the Alcon AcrySof® IQ Vivity® IOL or the Acunex® Vario IOL), will be included.
All qualitative variables will be summarized as the distribution of frequency, absolute and percentage. For all quantitative variables, descriptive statistics (including mean [or median], SD, minimum and maximum values) will be calculated for all necessary parameters. All data will be presented as means with standard deviation or proportions with percentages. The frequency and proportion of patients with postoperative medical and lens complications, and ocular/visual symptoms will also be reported. SPSS will be used to determine the differences between groups and between pre- and postoperative assessments and evaluate whether these are equal (within the non-inferiority margin of 0.1 logMAR). T-tests for independent samples will be used to evaluate to what extent the outcomes of both study-groups are comparable, considering a non-inferiority margin of 0.1 logMAR. Further, paired t-tests will be used to analyse the changes in visual acuities between the preoperative and postoperative visits.
The student's t-test requires normally distributed variables. If this assumption is not true, the more robust non parametric Wilcoxon rank sum test or Mann-Whitney U test, when appropriate, will be used. In all tests the threshold of statistical significance will be assumed equal to p=0.05
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Bilateral, Lens, Intraocular, Lens Implantation, Intraocular, Pseudophakia, Visual Acuity
Keywords
Extended depth of Focus intraocular lenses, Intermermediate visual acuity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study design is a single-center, double masked, prospective randomized clinical study. The study will be conducted at the University Eye Clinic Maastricht of the Maastricht University Medical Centre+ (MUMC+) in the Netherlands.
The study consists of two study groups: Vario-group (implantation with the Acunex® Vario IOL) and the Vivity-group (implantation with the Alcon AcrySof® IQ Vivity® IOL). A total of 32 patients will be randomized into either the Vario-group or the Vivity-group at a 1:1 ratio. Patients and study-optometrists will be masked. Surgeons are impossible to mask, due to the difference in (optical) design between both IOLs. Patients will receive standard cataract extractions by experienced surgeons.
Masking
Participant
Masking Description
Study optometrists (who will perform the examinations)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vario-group
Arm Type
Experimental
Arm Description
Patients in this group recieve the Acunex Vario IOL bilaterally during the cataract surgery.
Arm Title
Vivity-group
Arm Type
Active Comparator
Arm Description
Patients in this group recieve the Alcon Acrysof IQ Vivity IOL bilaterally during the cataract surgery.
Intervention Type
Device
Intervention Name(s)
Acunex Vario intraocular lens
Intervention Description
This is an extended depth of focus IOL, made by Teleon Surgical B.V.
Intervention Type
Device
Intervention Name(s)
Alcon AcrySof IQ Vivity intraocular lens
Intervention Description
This is an extended depth of focus IOL, made by Alcon.
Primary Outcome Measure Information:
Title
Binocular uncorrected intermediate visual acuity
Description
The visual acuity will be measured at 66cm under photopic conditions
Time Frame
3 months postoperatively
Secondary Outcome Measure Information:
Title
Mono- and binocular uncorrected and corrected distance visual acuity
Description
The visual acuities will be measured at 4 meters under photopic conditions
Time Frame
At week 1, 1 month and 3 months postoperatively
Title
Mean binocular distance-corrected intermediate visual acuity
Description
The visual acuity will be measured at 66cm under photopic conditions
Time Frame
At 1 and 3 months postoperatively
Title
Mean binocular uncorrected near visual acuity and distaqnce corrected near visual acuity
Description
The visual acuity will be measured at 40cm under photopic conditions
Time Frame
At 1 and 3 months postoperatively
Title
Binocular defocus curves
Description
Under photopic conditions
Time Frame
At 3 months postoperatively
Title
Mean binocular constrast sensitivity
Description
Under photopic and mesopic conditions
Time Frame
At 3 months postoperatively
Title
Complication profile including halos and glare
Description
According to the 4-point likert scale (ranging from 'no' to 'very disturbing')
Time Frame
Up to 3 months postoperatively
Title
Questionnaires on patient satisfaction rate
Description
Using questionnaire: Catquest-NL, including different questions and answer options of satisfaction rate (4-point scale ranging from 'very dissatisfied' to 'very satisfied')
Time Frame
Preoperatively and at 3 months postoperatively
Title
Questionnaires on patient difficulty rate
Description
Using questionnaire: Catquest-NL, including different questions and answer options of difficulties (4-point scale ranging from 'Very big difficulties' to 'no difficulties').
Time Frame
Preoperatively and at 3 months postoperatively
Title
Questionnaires on occurence of optical complaints
Description
Using questionnaires: QoV-NL, including different questions and answer options about how often the complaints happen (4-point scale ranging from 'never' to 'very often').
Time Frame
At 3 months postoperatively
Title
Questionnaires on the bothersome of optical complaints
Description
Using questionnaires: QoV-NL, including different questions and answer options about how bothersome it is for the patient (4-point scale ranging from 'Not at all' to 'Very').
Time Frame
At 3 months postoperatively
Title
Questionnaires on spectacle independence
Description
Using questionnaires: IOLSAT, including different questions and 5-point scale answer options ranging from 0 (Never) to 4 (Always)
Time Frame
At 3 months postoperatively
Title
Tilt and decentration intraocular lens
Description
Using Optical Coherence Tomography scans
Time Frame
At 1 month postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Minimum 18 years of age
Bilateral cataract
Bilateral implantation of either Acunex® Vario IOL or the Alcon AcrySof® IQ Vivity® IOL
Expected postoperative astigmatism ≤ 1.00 D (use of femtosecond laser assisted cataract surgery (FLACS) AK's tolerated up to 1.5 D of corneal astigmatism preoperative)
Bilateral implantation of a non-toric Acunex® Vario IOL or a non-toric Alcon AcrySof® IQ Vivity® IOL
IOL power calculation between +10.00 D and +30.0 D
Expected postoperative best-corrected visual acuity of logMAR 0.3 or better
Availability to undergo second eye surgery on the same day or else within 2 weeks of the first eye surgery
Willing and able to comply with scheduled visits and other study procedures
Signed informed consent
Exclusion Criteria:
Previous corneal surgery and/or reshaping
Corneal pathology (i.e., fuchs endothelial dystrophy (FED), irregular astigmatism, herpes simplex virus (HSV) keratitis
Extensive age-related macular degeneration (atrophic or exudative age-related macular degeneration or numerous soft drusen) and post-intravitreal injection (IVI)
Extensive visual field loss (eg. glaucoma, cerebral vascular accident (CVA), hemianopsia, etc.)
Extensive diabetic retinopathy
Amblyopia, strabismus, diplopia
Pseudo exfoliation syndrome or other capsule or zonular abnormalities that could affect postoperative centration or tilt of the IOL
Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic /scotopic conditions)
Cognitive cerebral or concentration disorders (e.g., dementia, Parkinson, stroke, etc.)
Suturing of incision required at time of surgery
Complications during surgery of the first eye.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudy Nuijts, MD, PhD
Organizational Affiliation
University Eye Clinic Maastricht UMC+
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht UMC+
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Only the results of the study will be published in report form and submitted for publication in appropriate journals in the international literature. IPD data will not be shared.
Citations:
PubMed Identifier
28780781
Citation
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Results Reference
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26432120
Citation
Jonker SM, Bauer NJ, Makhotkina NY, Berendschot TT, van den Biggelaar FJ, Nuijts RM. Comparison of a trifocal intraocular lens with a +3.0 D bifocal IOL: results of a prospective randomized clinical trial. J Cataract Refract Surg. 2015 Aug;41(8):1631-40. doi: 10.1016/j.jcrs.2015.08.011. Erratum In: J Cataract Refract Surg. 2017 Jan;43(1):148-150.
Results Reference
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PubMed Identifier
23332253
Citation
de Vries NE, Nuijts RM. Multifocal intraocular lenses in cataract surgery: literature review of benefits and side effects. J Cataract Refract Surg. 2013 Feb;39(2):268-78. doi: 10.1016/j.jcrs.2012.12.002.
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Citation
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Webers VSC, Bauer NJC, Saelens IEY, Creten OJM, Berendschot TTJM, van den Biggelaar FJHM, Nuijts RMMA. Comparison of the intermediate distance of a trifocal IOL with an extended depth-of-focus IOL: results of a prospective randomized trial. J Cataract Refract Surg. 2020 Feb;46(2):193-203. doi: 10.1097/j.jcrs.0000000000000012.
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Erie JC, Simpson MJ, Bandhauer MH. A modified intraocular lens design to reduce negative dysphotopsia. J Cataract Refract Surg. 2019 Jul;45(7):1013-1019. doi: 10.1016/j.jcrs.2019.01.019. Epub 2019 Apr 16.
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Evaluation of Visual Function After Bilateral Implantation of EDOF IOLs
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