Intraoperative Berger Space Imaging
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The primary objective is a Berger Space larger than 400μm
研究概览
简要总结
The investigational device is an approved femtosecond laser (FSL) device with an integrated imaging system to perform certain steps of the cataract procedure. The FSL will perform anterior capsulotomy and lens fragmentation in individuals suffering from age-related cataract with need of cataract surgery.
The laser will be reduced to image the Berger space. If not visible, the space will be enhanced with BSS and Volon A to visualize the BS.
Cataract surgery will be performed in subjects who have signed an informed consent form. Macula thickness will be measured with Spectralis OCT on screening date.
Postoperative examinations will be implemented in accordance with the approved investigational plan on subjects and includes: visual acuity, slitlamp examination and retinal oct imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 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
- •Age: 40 to 90 (females of childbearing age will be interviewed if pregnancy is possible)
- •Preoperative pupil size in mydriasis ≥ 6.0 mm
排除标准
- •Preceding ocular surgery or trauma
- •Pseudoexfoliation
- •Recurrent intraocular inflammation of unknown etiology
- •Uncontrolled glaucoma
- •Uncontrolled systemic or ocular disease
- •Blind fellow eye
- •Microphthalmus
- •Corneal abnormality
- •History of uveitis/iritis
- •Iris neovascularization
- •Proliferative diabetic retinopathy
- •Macular degeneration or any other relevant macular diseases
- •Pregnancy
结局指标
主要结局
The primary objective is a Berger Space larger than 400μm
时间窗: intraoperative
The number of patients with visible Berger space and the capacity (volume) of the visible Berger Space will be determined by using the intraoperative OCT recording
次要结局
- Difference of central macular thickness between time points(Baseline to 1day, 1 week, 3 weeks)
- Intraocular pressure in different timepoints(Baseline to 1day, 1 week, 3 weeks)
研究者
Rupert Menapace
Clinical Professor
Medical University of Vienna