Rotational Stability of a Hydrophobic Acrylic Plate Haptic Intraocular Lens Using a Capsular Tension Ring - An Intraindividual Comparative Study
试验速览
- 阶段
- 不适用
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Change of axial intraocular lens position
研究概览
简要总结
The present study should investigate the influence of a capsular tension ring on postoperative rotational stability of a plate haptic hydrophilic acrylic intraocular lens. All patients will be operated on both eyes in one occasion. Both eyes receive a Zeiss 409MP plate haptic intraocular lens, while only on eye receives an additional capsular tension ring. Follow up visits take place 1 hour, 1 week, 1 month and 4 to 7 months after surgery. At the follow up visits, the actual IOL axis will be determined by retroillumination photography. IOL centration and tilt will be determined by anterior segment SS-OCT Casia II. IOLs will be implanted in 4 different axis 0 +/- 10 degrees, 45 +/- 10 degrees, 90 +/- 10 degrees, 135 +/- 10 degrees. IOL rotation, decentration and tilt then will be compared intraindividually.
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
- Single (Investigator)
盲法说明
Investigator will be masked to which axis the IOL will be implanted until a sealed envelope will be opened in the operating theater.
入排标准
- 年龄范围
- 45 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation
- •Need for spherical IOL correction between +0.00 and +32.00 D
- •Pupil dilation of ≥ 7.0 mm
- •Age 45 to 95
排除标准
- •Corneal abnormality (Corneal scaring)
- •Preceding ocular surgery or trauma
- •Uncontrolled glaucoma
- •Proliferative diabetic retinopathy
- •Iris neovascularization
- •History of uveitis/iritis
- •Microphthalmus
- •Recurrent intraocular inflammation of unknown etiology Uncontrolled systemic or ocular disease
- •Pregnancy
- •Lactation
结局指标
主要结局
Change of axial intraocular lens position
时间窗: 7 months
Change in axis position of an intraocular lens Zeiss 409 MP from end of surgery (baseline axis) to 1 hour, 1 week, 1 month and 4-7 months (end of study visit). The change in axis position will be evaluated with respect to the baseline measurement at the end of surgery. Differences in axis position will be described as rotation in degrees (0 to 360°)
次要结局
- Anterior chamber depth(7 months)
- Best corrected visual acuity (BCVA)(7 months)
- Tilt(7 months)
- Decentration(7 months)
研究者
Rupert Menapace
Ao. Univ. Prof. Dr.
Medical University of Vienna