Anatomic and Functional Outcomes of 23-gauge Vitrectomy Combined With Posterior Subtenon Triamcinolone Injection for the Treatment of Idiopathic Epiretinal Membrane
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes of best corrected visual acuity and central retinal thickness
研究概览
简要总结
This study compares the anatomical and visual outcomes of patients with idiopathic epiretinal membrane(ERM) treated by vitrectomy and membrane peeling with or without subtenon triamcinolone acetonide injection
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
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.The participant must have idiopathic epiretinal membrane 2.The participant must be willing and able to comply with the protocol.
排除标准
- •The participant has idiopathic epiretinal membrane with other ocular vascular diseases such as Diabetes retinopathy, BRVO, etc.
- •The participant has any additional ocular diseases that have irreversibly compromised or could likely compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema, severe non proliferative diabetic retinopathy, or proliferative diabetic retinopathy.
- •The participant has had intraocular surgery (including lens replacement surgery).
- •The participant has a history of (within the last six months), or current ocular or periocular infection (including any history of ocular herpes zoster or simplex).
研究组 & 干预措施
Vitrectomy only group
The patients who will underwent 23- gauge transconjunctival sutureless vitrectomy only.
干预措施: Vitrectomy only group (Procedure)
Combined therapy group
The patients who will underwent 23- gauge transconjunctival sutureless vitrectomy with concomitant posterior subtenon Triamcinolone acetate injection.
干预措施: Combined therapy group (Procedure)
结局指标
主要结局
Changes of best corrected visual acuity and central retinal thickness
时间窗: 6 months
Changes of best corrected visual acuity and central retinal thickness on optical coherence tomography (OCT) at baseline and 1, 3, 6 months after injection
次要结局
- Changes in status of ISOS line(6 months)
研究者
Min Sagong
Assistant Professor
Yeungnam University College of Medicine