Corneal Flap Transplantation for Macular Hole Repair of High Myopia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- reattachment of the retina
研究概览
简要总结
The goal of this clinical trial is to learn about an innovative surgical technique for macular hole repair. This technique is for patients with high myopia using pars plana vitrectomy (PPV) combined with corneal flap transplantation. The main questions it aims to answer are:
- Is the innovative surgical technique useful for patients?
- Is the surgical technique safe for patients?
Participants will:
- Undergo PPV combined with corneal flap transplantation to cover the macular hole.
- Maintain a prone position for 2 weeks postoperatively.
- Be observed by visual acuity, slit lamp, optical coherence tomography (OCT) and fundus photography for 1 year after surgery.
详细描述
We describe an innovative surgical technique for macular hole repair using pars plana vitrectomy (PPV) combined with corneal flap transplantation. The corneal flap was sealed with autologous blood. The vitreous cavity was then filled with perfluoropropane (C3F8) or sterile air.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with macular hole and retinal detachment caused by pathologic myopia.
排除标准
- •Patients with previous retinal surgery, trauma, other ocular diseases that could affect the vision, for example choroidal neovascularization, diabetic retinopathy, or opaque corneas were excluded.
结局指标
主要结局
reattachment of the retina
时间窗: one month to one year after surgery
reattachment of the retina observed using optical coherence tomography
best-corrected visual acuity
时间窗: one month to one year after surgery
the best-corrected visual acuity of the patients after surgery
complications
时间窗: one month to one year after surgery
inflammation, infection, rejection reaction, ocular hypertension, ocular hypotension, recrudescent macular hole, parafoveal atrophy, corrugations or irregularities, choroidal neovascularisation, retinal detachment, cystoid macular oedema, reactive pigment epithelial hyperplasia, displacement, or opacification of the corneal flap
closure of the macular holes
时间窗: one month to one year after surgery
closure of the macular holes observed using optical coherence tomography
次要结局
未报告次要终点