Comparative Study Between Pars Plana Vitrectomy With Internal Limiting Membrane Peeling With or Without Planned Foveal Detachment for Management of Non-tractional Refractory Diabetic Macular Edema
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- change in CMT by OCT at final visit
研究概览
简要总结
To evaluate the efficacy and safety of combined pars plana vitrectomy and planned foveal detachment through subretinal injection of ringer's solution in patients with non-tractional refractory diabetic macular edema.
详细描述
In non-tractional cases, PPV allows a more efficient clearance of VEGF and other cytokines from the retina and improves retinal oxygenation by promotion of intraocular fluid currents, and relief of any subclinical tractional forces, thereby reducing DME.
To evaluate the efficacy and safety of combined pars plana vitrectomy and planned foveal detachment through subretinal injection of ringer's solution in patients with non-tractional refractory diabetic macular edema.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: above 40 years old.
- •Patients with type two diabetes mellitus of more than 5 years duration.
- •Patients with Best corrected visual acuity better than 3/
- •Central macular thickness (CMT) of more than 250 μm despite undergoing six monthly injection of anti-VEGF therapy or corticosteroid or less than 10% reduction in CMT at the last follow up visit.
- •No evidence of vitreomacular traction.
- •Lens status: Pseudophakia or clear crystalline lens.
排除标准
- •Other causes of macular edema (intraocular inflammation, retinal vein occlusion, Irvin-gass syndrome, pharmacological).
- •Ischemic maculopathy by FFA.
- •Presence of bad prognostic signs in OCT such as disorganization of inner retinal layers (DRIL) and extensive disruption of IS-OS junction subfoveally.
- •Presence of apparent retinal pigment epithelium (RPE) atrophy at or near the macula.
- •Presence of proliferative diabetic fibrovascular membranes threatening or at the macula.
- •Presence of diabetic optic atrophy or neuropathy.
- •Presence of neovascular glaucoma.
- •Cataractous lens either preoperatively or as intra or postoperative complication.
- •Vitrectomized Eyes.
- •A prior intraocular surgery within the past six-months.
- •Lost follow up
结局指标
主要结局
change in CMT by OCT at final visit
时间窗: after 1 month and 3 months
decrease or increase in central macular thickness by OCT
次要结局
- change in BCVA at final visit(after 1 month and 3 months)