Gore-Tex Suture and BunnyLens Scleral Fixation - Historical Retrospective Trial
试验速览
- 阶段
- 不适用
- 发起方
- DAVID HAUSER
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Distance Visual Acuity
研究概览
简要总结
This study evaluates the Visual Acuity and refraction of patients post 4-point Scleral fixation of BunnyLens (Intra Ocular Lens- IOL) with GoreTex sutures. All patients underwent secondary IOL implantation or IOL exchange during 2014-2017.
详细描述
4 point scleral fixation of PC- IOL (Posterior Chamber-PC) BunnyLens with Gore-Tex sutures is a surgical technique for implanting IOL in patients with capsular support absence, due to trauma, abnormal anterior chamber, IOL dislocation, or ciliary zonule defect.
The 4 point fixation enables to align the PC- IOL with minimal vertical and horizontal deviation;The Gore-Tex sutures maintain stable scleral fixation with no suture erosion or breakage.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 15 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients that underwent secondary cataract surgery or IOL replacement and BunnyLens fixation with Gore-Tex sutures.
排除标准
- •Lack of Cooperation, death, severe physical or mental illness, patient's request to withdraw of the clinical trial.
结局指标
主要结局
Distance Visual Acuity
时间窗: Up to 24 months from surgery.
Degree of Visual Acuity is measured in LogMar (-0.3 to1) and by Decimal Value (0.0-2.0)
Ocular Refraction
时间窗: Up to 24 months from surgery.
Refraction of the Ocular surfaces, measured in sphere, cylinder and axis.
次要结局
- Slit Lamp Biomicroscopy(Up to 24 months from surgery.)
研究者
DAVID HAUSER
Retina Ophthalmologist
Barzilai Medical Center