Comparative Study of Two Multifocal Intraocular Lens With Different Add Power
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Visual Acuity
研究概览
简要总结
This study will compare cataract patients with implantation of diffractive multifocal IOL with an additional power of +2.75 diopters (Group 1) and with +3.25 diopters (Group 2). Evaluations will be performed 1 and 3 months following cataract surgery, including measurement of uncorrected distance visual acuity (UDVA), refractive error (manifest refraction [MR]), and uncorrected near visual acuity (UNVA) at 33, 40, and 50 cm. At 3 months, internal aberrations and contrast sensitivity will be evaluated and subjects will complete a questionnaire on outcomes satisfaction, visual symptoms, and spectacle use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >= 18
- •cataract patients with lens opacities classification higher than grade III
- •patients who desire to be spectacle indepence for distance and near vision
排除标准
- •previous ocular surgery or trauma
- •presence of corneal opacities
- •fundus abnormalities
- •amblyopia
- •systemic disease
- •posterior capsule rupture during cataract surgery
研究组 & 干预措施
2.75 group
Patients with 2.75 diopters multifocal intraocular lens
干预措施: +2.75 diopters multifocal intraocular lens (Device)
3.25 group
Patients with +3.25 diopters multifocal intraocular lens
干预措施: +3.25 diopters multifocal intraocular lens (Device)
结局指标
主要结局
Visual Acuity
时间窗: 3 months
Uncorrected distance visual acuity and uncorrected near visual acuity
次要结局
- Contrast sensitivity measured by the Functional Acuity Contrast Test (FACT) of the Optec 6500 view-in test system(3 months)
- internal aberration measured by the ray-tracing aberrometer(3 months)