Suprachoroidal Buckling for the Management of Rhegmatogenous Retinal Detachment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 主要终点
- Treatment-related adverse event
研究概览
简要总结
Study of novel surgical technic-suprachoroidal buckling for therapy of rhegmatogenous retinal detachment.It was excpted to reattached the retina and improve visual function of rhegmatogenous retinal detachment patients.
详细描述
The operation was performed under a surgical microscope with a 25G Chandelier light source and a wide-field observation system to observe the fundus.Location, marking and freezing of the retinal tear on the scleral side .
Subretinal fluid is released from the outside of the sclera as needed. The spherical conjunctiva was opened and the radial full-thickness scleral incision (3mm)was made about 8-13mm away from the retinal tear. A "pocket" is formed by injecting some viscoelastic agent into the posterior edge of the sclera and separating the choroid from the sclera using the Healon packaged cannula (No.27 Rycroft cannula). The Healon 5 syringe was connected with a 450-um special tube (a 23 caliber curved tube with olive tip). The cannula is inserted into the supragromal space under microscopic and was scaned by iOCT . Monitor the location of retinal tear during intubation in real time, and adjust the position of the needle: posterior margin of the tear. Once confirmed in accord with the needle position, sodium hyaluronate injection, injection needles to in front of shift to injection, until the tear was completely surrounded in viscoelastic agent to create the choroid crest, usually need 0.2 mL to 0.5 mL. Exit the duct and close the incision with scleral presutures.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Clinical diagnosis of rhegmatogenous retinal detachment; (2)myopia < 600 degrees； (3) retinal tear were peripheral part, non-proliferative round hole or horseshoe tear, single or multiple tears within one oclock area; (4) PVR grading: Grade A, B, C1, C2; (5) Subretinal fluid was confined around the tear. (6)phakic.
排除标准
- •(1)Cataract, corneal degeneration, genetic diseases; (2)History of internal eye surgery; (3)The other eye was blind; (4)Postoperative follow-up could not be scheduled; (5)Systemic diseases (asthma, heart failure, myocardial infarction, liver failure, kidney failure and other serious diseases); (6)History of aspirin and other anticoagulant drugs; (7)Severe adverse reactions and systemic diseases occurred during follow-up.
结局指标
主要结局
Treatment-related adverse event
时间窗: 3 months post operation
Number of participants with treatment-related adverse events（including suprachoroidal hemorrhage, subretinal hemorrhage, vitreous hemorrhage）
Retina reattachment
时间窗: 3 months post operation
Number of participants who achieved retina reattachment assessed by fundus photography，b-scan ultrasonography and optical coherence tomography.
Best Corrected visual Acuity (BCVA）
时间窗: 3 months post operation
Patients' best corrected visual acuity assessed by logarithmic visual acuity charts.
Intraocular pressure (IOP)
时间窗: 3 months post operation
Patients' IOP assessed by noncontact tonometer
次要结局
- Best Corrected visual Acuity (BCVA）(12 months post operation)
- Intraocular pressure (IOP)(12 months post operation)
- Retina reattachment(12 months post operation)
- Treatment-related adverse event(12 months post operation)
研究者
Fang Wang
Chief of department of ophthalmology
Shanghai 10th People's Hospital