NCT06232616Enrolling By Invitation不适用
Vitrectomy Combined With Intravitreal Dexamethasone Implant for the Treatment of Idiopathic Epiretinal Membrane With Cystoid Macular Oedema
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- improvement of visual acuity
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and safety of 25-gauge pars plana vitrectomy combined with intravitreal dexamethasone implant for the treatment of idiopathic epiretinal membrane with cystoid macular oedema. The main questions it aims to answer are:
- mean changes in best corrected visual acuity and central macular thickness from baseline to post-operative 24 weeks
- mean change in proportion of cystoid macular oedema area from baseline to post-operative 24 weeks
- intraocular pressure throughout postoperative 24 weeks
- concentrations of inflammatory factors in vitreous samples Participants will undergo a standard three-port 25-gauge pars plana vitrectomy and epiretinal membrane peeling combined with phacoemulsification, aspiration, and intraocular lens implantation. The dexamethasone implant will be injected into the vitreous cavity at the end of the operation.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptomatic patients aged 40 years or above with idiopathic stage 3-4 epiretinal membrane defined on the basis of spectral-domain optical coherence tomography classification;
- •central retinal thickness >300 µm;
- •cystoid oedema within a 1 mm diameter range with the macular fovea as the center;
- •ocular axial length less than 25.00 mm.
排除标准
- •concomitant or previous macular diseases that may hinder visual improvement other than epiretinal membrane (e.g., age-associated macular degeneration, retinal vein occlusion, or diabetic macular oedema);
- •previous vitreoretinal surgery or intravitreal injection history;
- •history of glaucoma or optic neuropathy of any kind;
- •patients with uncontrolled systemic diseases or infectious diseases;
- •patients who took medicines that may have ocular side effects, such as glucocorticoid or hydroxychloroquine.
研究组 & 干预措施
Single arm
Other
In this single-arm designed study, participants with idiopathic epiretinal membranes with macular oedema were assigned a vitrectomy with an intravitreal dexamethasone implant.
干预措施: vitrectomy combined with intravitreal dexamethasone implant (Procedure)
结局指标
主要结局
improvement of visual acuity
时间窗: from baseline to postoperative 24 weeks
mean change in best corrected visual acuity
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular EdemaDiabetic Macular EdemaNCT00464685Allergan253
已完成
2 期
Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular EdemaDiabetic Macular EdemaVitrectomyNCT00799227Allergan56
已完成
3 期
A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular EdemaDiabetic Macular EdemaNCT00168337Allergan554
已完成
3 期
A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein OcclusionMacular EdemaRetinal Vein OcclusionNCT00168298Allergan668
终止
2 期
A Study of the Safety and Efficacy of a New Treatment for Non-Infectious Anterior UveitisAnterior UveitisNCT00333996Allergan5