Effect of Intraocular Tamponade on Visual Function in the Human Eyes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Retinal function implicit time.
研究概览
简要总结
Intraocular tamponade used in vitrectomy operations may affects retinal function in various mechanisms.
详细描述
Various intraocular tamponade are being used in vitrectomy operations as gases, fluids and silicon oil. The effects of these intraocular tamponade may affects the final visual outcome of the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary retinal detachment patients.
- •patients eligible for 23 gauge pars-plana vitrectomy operation.
排除标准
- •patients with axial length more than 30 millimeter that may have severe chorioretinal degenerations that may affects retinal function.
- •patients with macular diseases that may affects final visual outcome as macular holes and choroidal neovascular membranes.
研究组 & 干预措施
Non-expansile gas
Patients diagnosed with retinal detachment and undergone vitrectomy operation with non-expansile gas tamponade (sulfur hexafluoride).
干预措施: Vitrectomy operation (Procedure)
Non-expansile gas
Patients diagnosed with retinal detachment and undergone vitrectomy operation with non-expansile gas tamponade (sulfur hexafluoride).
干预措施: Electroretinogram (Diagnostic Test)
Silicon oil group
Patients diagnosed with retinal detachment and undergone vitrectomy operation with silicon oil tamponade.
干预措施: Electroretinogram (Diagnostic Test)
Silicon oil group
Patients diagnosed with retinal detachment and undergone vitrectomy operation with silicon oil tamponade.
干预措施: Vitrectomy operation (Procedure)
Air tamponade
Patients diagnosed with retinal detachment and undergone vitrectomy operation with air tamponade.
干预措施: Electroretinogram (Diagnostic Test)
Air tamponade
Patients diagnosed with retinal detachment and undergone vitrectomy operation with air tamponade.
干预措施: Vitrectomy operation (Procedure)
结局指标
主要结局
Retinal function implicit time.
时间窗: Baseline and monthly after surgery till 6 months of follow up.
Changes in electroretinogram implicit time in millisecond measured by roland consult retinal function device.
Visual acuity
时间窗: Baseline and monthly after surgery till 6 months of follow up.
Changes in visual acuity measured in LogMAR units.
Retinal function amplitude
时间窗: Baseline and monthly after surgery till 6 months of follow up.
Changes in electroretinogram amplitude parameters in microvolt/second measured by roland consult retinal function device.
次要结局
- Intraocular pressure(Baseline and monthly after surgery till 6 months of follow up.)
研究者
Ahmed Abdelshafy
Lecturer of Ophthalmology
Benha University