The Use of FCSB in Medium-complex RRD - a Safety and Efficacy Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- anatomic success rate
研究概览
简要总结
The objective of the study is to evaluate:
- Safety and efficacy of a novel foldable capsular scleral buckle (FCSB) in scleral buckling for primary rhegmatogenous retinal detachment (RRD) of medium complexity.
- Comparison between FCSB and pars plana vitrectomy in therapeutic effects and complications in the treatment of primary RRD of medium complexity.
详细描述
Pars plana vitrectomy (PPV) and scleral buckling (SB) are major choices in treating rhegmatogenous retinal detachment (RRD) of medium complexity. PPV is more prevailed since it improved internal search for breaks and elimination of vitreous traction. SB has unmatched advantages over PPV such as earlier rehabilitation, free from prolonged positioning, less complicated cataract or glaucoma. The novel foldable capsular scleral buckle (FCSB) can create a big bulge by pressing on the sclera and seal the break in bullous RRD without scleral drainage. In the study, differences of anatomic and functional results between PPV and FCSB in treating primary RRD of medium complexity are evaluated.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One or more retinal holes which cannot be treated sufficiently with a single silicon sponge or silicone band (e.g. large holes, multiple holes, multiple holes of varying anterior-posterior localisation, massive traction)
- •Exclusion Criteria
- •simple rhegmatogenous retinal detachment which can be treated with a single silicon sponge or silicone band (e.g. single holes, no traction, limit retinal detachment)
- •Complicated RRD, including macular hole within the arcade, PVR C or D, severe cataract, severe vitreous hemorrhage, unclear macular hole,
- •Combined with other eye diseases that affect vision prognosis.
- •History of other eye surgeries including cataract surgery.
- •Presence of systemic diseases that may affect postoperative observation and follow-up.
排除标准
- 未提供
结局指标
主要结局
anatomic success rate
时间窗: From enrollment to the end of treatment at 6 months
The success rate of retinal reattachment
metamorphopsia
时间窗: From enrollment to the end of treatment at 6 months
metamorphopsia is measured by M chart
Visual Results
时间窗: From enrollment to the end of treatment at 6 months
Best-Corrected Visual Acuity, and is measured by Snellen Chart, EDTRS Chart and charts designed for people with low vision
次要结局
- The number of surgeries that achieved successful final retinal reattachment(From enrollment to the end of treatment at 6 months)
- Surgical Complications(From enrollment to the end of treatment at 6 months)