NCT02639507已完成不适用
International Consortium Investigating Early Vitrectomy in Diabetic Macular Edema Patients - the ICV-DME Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- average (mean) improvement in Best Corrected Visual Acuity (BCVA) as measured with Snellen visual acuity
研究概览
简要总结
The purpose of this research is to evaluate the effectiveness of vitrectomy for the treatment of diabetic macular edema. Diabetes is known to cause retinal blood vessels to leak, leading to swelling of the central retina (macula), and decreased vision. Removing the vitreous gel with vitrectomy surgery is known to decrease the swelling caused by diabetes. Diabetic retinopathy is often treated with laser or injections of medicine in to the eye.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Men and women, > 18 years of age with type 1 or 2 diabetes mellitus diagnosed and treated by an endocrinologist, internist or family medicine physician
- •Background diabetic retinopathy
- •DME with central subfield thickness (CST) > 325 µm by Spectral Domain Optical Coherence Tomography (SD-OCT)
- •HbA1c level of < 10.0 mg/dl
- •Previous cataract surgery with implantation of a stable posterior chamber intraocular lens or a phakic eye with 1+ (out of 4+ scale) or less lens opacification
- •Predominantly intact (80%) external limiting membrane (ELM) and photoreceptor inner/outer segment (IS/OS) lines within 500 µm of the fovea on horizontal and vertical SD-OCT scans
- •Best corrected Snellen visual acuity from 20/40 to 20/280 inclusive.
排除标准
- •Intraocular anti-vascular endothelial growth factor (VEGF) injection within the previous 3 months
- •Systemic anti-VEGF or receptor tyrosine kinase inhibitor therapy within the previous 3 months
- •Intraocular corticosteroid injection within the previous 6 months
- •Peri-ocular corticosteroid injection within the previous 3 months
- •Vitreomacular traction on SD-OCT scan (epiretinal membrane is allowed)
- •Previous anterior or pars plana vitrectomy
- •Glaucoma (IOP of > 21 mmHg or regular use of more than 2 IOP lowering drugs)
- •Previous trabeculectomy
- •Likelihood of needing intraocular surgery within 6 months
- •Hard exudates involving the fovea
- •Proliferative diabetic retinopathy with any evidence of retinal traction
- •Cataract of grade 2+ or greater.
结局指标
主要结局
average (mean) improvement in Best Corrected Visual Acuity (BCVA) as measured with Snellen visual acuity
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
A Feasibility Randomised Controlled Trial of Early Vitrectomy for Post-operative Exogenous EndophthalmitisEndophthalmitis Postoperative AcuteNCT04522661Moorfields Eye Hospital NHS Foundation Trust63
已完成
不适用
Evaluation of Vitrectomy for Diabetic Macular EdemaDiabetic Macular EdemaDiabetic RetinopathyNCT00709319Jaeb Center for Health Research87
已完成
3 期
Diabetic Retinopathy Vitrectomy Study (DRVS)Vitreous HemorrhageRetinal DetachmentDiabetic RetinopathyNCT00000154National Eye Institute (NEI)
已完成
不适用
Early VItrectomy in DENse Spontaneous Vitreous HEmorrhageSpontaneous Vitreous HemorrhageRetinal BreakRetinal DetachmentNCT04676256Assistance Publique - Hôpitaux de Paris8
Unknown
早期 1 期
Safety and Effectiveness of Intravitreal Conbercept for Exudative Circumscribed Choroidal HaemangiomaCircumscribed Choroidal HaemangiomaNCT03571282Sun Yat-sen University50