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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 36
- 主要终点
- Intermediate Visual Acuity (Corrected and Uncorrected)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The patient and the examiner will be blinded to the arms.
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 30 years of age or older
- •Has bilateral cataracts with visual problems
- •Is motivated for vision correction
排除标准
- •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
研究组 & 干预措施
Extended depth of focus intraocular lens
Bilateral implantation of extended depth of focus intraocular lenses.
干预措施: Intraocular lens (Device)
Trifocal intraocular lens
Bilateral implantation of trifocal intraocular lenses.
干预措施: Intraocular lens (Device)
结局指标
主要结局
Intermediate Visual Acuity (Corrected and Uncorrected)
时间窗: 3 months after bilateral implantation
66 cm
Near Visual Acuity (Corrected and Uncorrected)
时间窗: 3 months after bilateral implantation
40 cm
Distance Visual Acuity (Corrected and Uncorrected)
时间窗: 3 months after bilateral implantation
4 m
次要结局
- Defocus Curve(3 months after bilateral implantation)
- Higher Order Abberations(3 months after bilateral implantation)
- Objective Automated Refraction(3 months after bilateral implantation)
- Contrast Sensitivity(3 months after bilateral implantation)
- Halos and Glares(3 months after bilateral implantation)