A Comparison of the Visual Performance of Trifocal Versus Extended Depth of Focus Intraocular Lenses

Study Overview
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Brief Summary
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We are conducting a trial evaluating the performance of trifocal versus extended depth of focus intraocular lenses. These lenses will be implanted in otherwise healthy individuals with visual problems due to bilateral cataracts. Patients must be seeking an improvement in their visual performance with a special focus on presbyopia correction.

Detailed Description
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To compare the clinical performance, quality of vision and subjective outcomes between the extended depth of focus (EDOF) Mini Well Ready intraocular lens (IOL) and the diffractive trifocal PanOptix IOL, at 3 months following second eye implantation. Statistical analysis All data will be analyzed using the Statistical Package for the Social Sciences (SPSS) v23 (SPSS Inc., Chicago, IL, USA). Graphs will be made using SPSS and Microsoft Excel (Microsoft Corp., Redmond, WA, USA). Normality will be tested for using the Shapiro Wilk test. If the data is normal, an independent t test will be used for comparing the continuous variables between the groups. If the data is not normal, then we will utilize the Mann Whitney U test. Sample size calculation The sample size calculation was based on the mean binocular Uncorrected Near Visual Acuity (UNVA) tested at 40cm under photopic condition. A previous study on the same diffractive trifocal IOL revealed a binocular UNVA of 0.01 ± 0.087 logMAR (12). The anticipated mean value for Mini Well Toric Ready is 0.10 logMAR. Based on these assumptions, an alpha of 0.05 and power of 0.8, it was calculated a number of 15 patients implanted bilaterally for each group. Assuming a dropout rate of 20% on the primary outcome measure, this resulted in a total number of 36 bilateral patients, 18 each group. Duration of the project: Six months to one year

Official Title
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A Randomized, Controlled, Two-armed, and Single Blind Trial Evaluating the Visual Performance and Quality of Vision After Bilateral Implantation of 2 Presbyopia Correcting Intraocular Lenses: Trifocal Versus Extended Depth of Focus

Conditions
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Cataract, Lenses, Visual Impairment

Intervention / Treatment
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* Device: Intraocular lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 30 years of age or older Has bilateral cataracts with visual problems Is motivated for vision correction Exclusion Criteria: Any ocular pathology that could impair vision, for example: Pseudoexfoliation syndrome Zonular weakness Retinal or corneal dystrophies Retinal pathologies like age related macular degeneration History of trauma History of ocular surgery Individuals having trouble understanding written or spoken language Those with dense cataracts causing problems with optical biometry Average corneal powers outside the range of 41 diopters (D) to 46 D Corneal astigmatism > 0.75 D Irregular astigmatism index of 0.54 or higher

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly allocated to one of two arms: Trifocal or extended depth of focus intraocular lenses.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extended depth of focus intraocular lens<br>Bilateral implantation of extended depth of focus intraocular lenses. | Device: Intraocular lens<br>* Bilateral implantation of the same intraocular lens.<br>* Other names: Phacoemulsifcation;|
| Active Comparator: Trifocal intraocular lens<br>Bilateral implantation of trifocal intraocular lenses. | Device: Intraocular lens<br>* Bilateral implantation of the same intraocular lens.<br>* Other names: Phacoemulsifcation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Near Visual Acuity (Corrected and Uncorrected) | 40 cm | 3 months after bilateral implantation | 
| Intermediate Visual Acuity (Corrected and Uncorrected) | 66 cm | 3 months after bilateral implantation | 
| Distance Visual Acuity (Corrected and Uncorrected) | 4 m | 3 months after bilateral implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defocus Curve | Evaluating presbyopia correction | 3 months after bilateral implantation | 
| Objective Automated Refraction | Using a auto refractometer (Topcon KR-800, Tokyo, Japan) | 3 months after bilateral implantation | 
| Contrast Sensitivity | At 2.5 m | 3 months after bilateral implantation | 
| Higher Order Abberations | Using a Abberometer | 3 months after bilateral implantation | 
| Halos and Glares | Using custom software provided by SIFI | 3 months after bilateral implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract, Intraocular lenses, Trifocal intraocular lenses, Extended depth of focus intraocular lenses, Presbyopia