A Prospective, Randomized, Controlled, Multicentered Study of Vitrectomy With Silicone Oil Tamponade for Hypermyopic Foveoschisis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Complete resolved rate of foveoschisis observed on OCT image.
研究概览
简要总结
The purpose of this study is to explore the efficiency and safety of the surgical procedure of pars plana vitrectomy with silicone oil tamponade and without internal limiting membrane peeling for myopic foveoschisis eyes with high risk of macular hole formation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with spherical ≥ -8 diopters or axial length ≥ 26.5mm.
- •The foveoshisis combined with foveal detachment was showed on the OCT image. The foveal detachment height≥ 250 um ,and the thickness of sensory retina of foveal detachment was ≤100 um;
- •patients signed the ICF.
- •patients with BCVA ≤0.5,and with visual disturbance symptoms.
排除标准
- •patients with macular hole
- •accompanied or secondary of other fundus disease
- •received vitrectomy due to other diseases
- •glaucoma cannot be controled by medication
- •patients with other retinal or choroidal disease that may affect VA
- •poor patients compliance
- •poor condition that cannot undertake the surgery
- •optical opacities which make it difficult to exam fundus or measure on OCT
研究组 & 干预措施
Gas group 1
Patients randomized into this group were received pars plana vitrectomy surgery with fovea-sparing internal limiting membrane peeling and gas tamponade.
干预措施: PPV with fovea-sparing ILMP and gas tamponade (Procedure)
Silicone oil group
Patients randomized into this group were received pars plana vitrectomy surgery with silicone oil tamponade and without internal limiting membrane peeling. And silicone oil tamponade was removed at least 12 months after the primary surgery with completely resolved of foveoschisis.
干预措施: PPV with SO tamponade (Procedure)
Gas group 2
Patients randomized into this group were received pars plana vitrectomy surgery with gas tamponade and without internal limiting membrane peeling.
干预措施: PPV with gas tamponade (Procedure)
结局指标
主要结局
Complete resolved rate of foveoschisis observed on OCT image.
时间窗: 18 months
The compete resolved of foveoschisis was evaluated using OCT image.
次要结局
- The posoperative macular hole formation rate.(18 months)
- Best corrected visual acuity (BCVA) change compared with baseline BCVA.(18 months)
研究者
Mingwei Zhao
Chief of Opthalmology department
Peking University People's Hospital