A Comparison of the Visual Performance of Trifocal Versus Extended Depth of Focus Intraocular Lenses
- Conditions
- LensesVisual ImpairmentCataract
- Interventions
- Device: Intraocular lens
- Registration Number
- NCT03726606
- Lead Sponsor
- Hashmanis Hospital
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 36
- Patient aged 30 years of age or older
- Has bilateral cataracts with visual problems
- Is motivated for vision correction
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Extended depth of focus intraocular lens Intraocular lens Bilateral implantation of extended depth of focus intraocular lenses. Trifocal intraocular lens Intraocular lens Bilateral implantation of trifocal intraocular lenses.
- Primary Outcome Measures
Name Time Method Intermediate Visual Acuity (Corrected and Uncorrected) 3 months after bilateral implantation 66 cm
Near Visual Acuity (Corrected and Uncorrected) 3 months after bilateral implantation 40 cm
Distance Visual Acuity (Corrected and Uncorrected) 3 months after bilateral implantation 4 m
- Secondary Outcome Measures
Name Time Method Defocus Curve 3 months after bilateral implantation Evaluating presbyopia correction
Higher Order Abberations 3 months after bilateral implantation Using a Abberometer
Objective Automated Refraction 3 months after bilateral implantation Using a auto refractometer (Topcon KR-800, Tokyo, Japan)
Contrast Sensitivity 3 months after bilateral implantation At 2.5 m
Halos and Glares 3 months after bilateral implantation Using custom software provided by SIFI