Evaluation of the Visual Acuity After the Implantation of an Oculentis +2.0 Diopters (Torical) Bifocal Intraocular Lens (MplusX (Toric) LU-313 MF20T/LS-313 MF20) in the Distance Dominant Eye, in Combination With a +3.0 Diopters Oculentis Bifocal Intraocular Lens (MplusX (Toric) LU-313 MF30T/LS-313 MF30) in the Fellow Eye.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Mesopic vision
研究概览
简要总结
The objective of this study is to assess the visual outcome after the combined binocular implantation of +2.0 D and +3.0 D refractive multifocal intraocular lenses.
详细描述
Bifocal multifocal intraocular lenses (MIOL) are effective in achieving good uncorrected visual acuities in the distance and the near. However, the intermediate vision is of increasing relevance for everyday's life. Several multifocal intraocular lenses have been developed to improvement intermediate vision. Nonetheless, those systems still possess adverse photic effects and do not garantuee spectacle independence. Therefore, the combination of a lower-addition bifocal intraocular lense in the distance-dominant eye with a higher-addition bifocal intraocular lense in the fellow-eye might be a promising approach to address these drawbacks of current binocular and trifocal intraocular lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically significant cataract
- •endothelial cell count: patients aged 18-75 years: > 1000 cells/mm2; patients > 75 years: > 750 cells/mm2
- •absence of vision-limiting corneal or retinal comorbidities
- •capability to understand the informed consent
排除标准
- •expected postoperative astigmatism > 0.75 diopters
- •irregular astigmatism
- •dilated pupil diameter < 3 mm
- •corneal and fundus abnormalities that might cause visual impairments
- •inability to attend follow-up visits
结局指标
主要结局
Mesopic vision
时间窗: 3 months
Mesopic visual acuities are tested under high-contrast, low-contrast and low-contrast with glare.
Scotopic contrast sensitivity
时间窗: 3 months
Scotopic contrast sensitivity are tested at 0.1 cd/m2, 0.032 cd/m2 and 0.1 cd/m2 with glare.
Visual acuities in the far, intermediate and near
时间窗: 3 months
Visual acuities are tested under photopic conditions at 5 m, intermediate (80 cm) and patient-preferred near distance (≈ 40 cm).
次要结局
- Spectacle independence in the far, intermediate and near(3 months)
研究者
PD Dr. med. Eckart Bertelmann
Senior Consultant
Charite University, Berlin, Germany