Safety and Efficacy Study of Macular Buckle With A Three-armed Silicone Capsule to Support the Posterior Staphyloma in High Myopia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- best corrected visual acuity
研究概览
简要总结
High myopia is characterized by prolonged axial length and posterior staphyloma, which result in choroid-retinal degeneration and vision decrease. At present, vitrectomy can lead to anatomical improvements, but an higher axial length and the presence of a sever posterior staphyloma remains to be the two most important risk factors for poor visual outcomes. For these reasons, a different surgical approach, including macular buckling, might be considered in those patients with extremely high degree of myopia, in order to counteract the traction exerted by the posterior staphyloma. Macular buckling with or without pars plana vitrectomy had been proved to be an effective way to resolve myopic staphyloma related foveoschisis, macular hole, and associated retinal detachment. In this study, we sought to investigate the safety and efficacy of a macular buckling technique using a three-armed silicone capsule to support the posterior staphyloma in high myopia.
详细描述
- This study plans to recruit 11 participants with 6 months follow-up to assess the safety and efficacy of a newly designed macular buckle device;
- The macular buckle device, surgical procedure, and participants registry had been reviewed and approved by Ethics committee of Zhongshan Ophthalmic Center;
- Only those patients are diagnosed with severe posterior staphyloma are registered.
- All participants are fully informed before register;
- All the surgeries are performed by single qualified doctor (Lin Lu);
- After operation, all participant could contact the researcher via telephone, and could be assessed for any surgical related complications. If there is severe complication happened, or any person that could not tolerant the macular buckle, the implanted device will be removed;
- Specially assigned staff (Jinge Lu) is responsible for data collection, data management, adverse events reporting, and participant communication.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •high myopia over -8.0 Diopter
- •axial length over 26.5 mm
- •posterior staphyloma
排除标准
- •single eye patients
- •retinal detachment beyond macular area
- •a history of posterior scleritis
- •a history of Glaucoma
- •active hemorrhage in the surgical eye
- •active inflammation in the surgical eye
- •any situation that might hinder the observation of macular
结局指标
主要结局
best corrected visual acuity
时间窗: 6 months
次要结局
- Optical coherence tomography(6 months)
- postoperative complications(6 months)
研究者
Lin Lu
Director, Fundus Disease Center of Zhongshan Ophthalmic Center
Sun Yat-sen University