Assessment of Retinal Vascular Changes With and Without ILM Peeling in Diabetic Vitrectomy Using Optical Coherence Tomography Angiography.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Compare the superficial and deep vascular densities using OCT-A with and without ILM peeling in diabetic vitrectomy patients.
研究概览
简要总结
Tractional retinal detachment (TRD) that involves the macula and non-clearing vitreous hemorrhage are the main causes of permanent vision loss in patients with diabetic retinopathy and requires prompt surgical intervention.
Macular peeling is a surgical technique used in many retinal diseases including diabetic retinal detachment.
Our purpose is to determine whether retinal microcirculatory changes occur after anatomically successful diabetic vitrectomy, and whether changes in blood flow vary if ILM peeling was done and whether changes in macular perfusion affect the final visual outcome.
The aim of this study is to non-invasively evaluate, with optical coherence tomography angiography (OCT-A), the anatomical changes of deep and superficial vascular density in the macula with and without macular peeling in diabetic vitrectomy.
详细描述
Background and Rationale:
Diabetic retinopathy (DR) is a leading cause of blindness among the working age group with increasing numbers of persons being affected worldwide.
The microvascular complications of diabetes result in macular leakage or exudation and vasoproliferative retinal disease, which are the hallmarks of advanced DR. Despite treatment of earlier stages of DR with medical therapy, several eyes will progress to require surgical treatment.
Surgical treatment for the advanced complications of DR can range from removal of a non-clearing vitreous hemorrhage, to more complicated surgical techniques such as in dealing with a combined tractional and rhegmatogenous retinal detachment (TRD/RRD) or tractional retinal detachment (TRD) involving or threatening the macula.
Tractional retinal detachment (TRD) that involves the macula is the main cause of permanent vision loss in patients with diabetic retinopathy and requires prompt surgical intervention. With the small-gauge vitrectomy system, anatomical success rate after pars plana vitrectomy (PPV) is reported to be over 90%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age above 18 years old of both sexes.
- •Patients having diabetic tractional retinal detachement threatening the macula (traction over posterior pole with attached fovea).
- •Combined tractional-rhegmatogenous retinal detachement with attached macula.
- •Diabetic persistent fibrovascular proliferation not responding to panretinal photocoagulation.
- •Non clearing diabetic vitreous hemorrhage, subhyaloid hemorrhage.
排除标准
- •Subject has had a previous vitrectomy (anterior or PPV) in the study eye.
- •Subject has uncontrolled neovascular glaucoma (intraocular pressure > 30 mmHg despite medical/surgical treatment) in the study eye.
- •Previous history of trauma in the study eye.
- •Previous history of Anti-VEGF injection.
- •Tractional macular detachment.
- •Coexisting macular hole.
- •Cases with previous arterial or venous occlusions.
- •Coexisting posterior segment inflammation.
结局指标
主要结局
Compare the superficial and deep vascular densities using OCT-A with and without ILM peeling in diabetic vitrectomy patients.
时间窗: 18 months total study duration , 9 months follow up
Compare the superficial and deep vascular densities in percentage compared to normative database using OCT-A (Optovue) with and without ILM peeling in diabetic vitrectomy patients.
Compare the foveal avascular zone using OCT-A between both groups.
时间窗: 18 months total study duration , 9 months follow up
Compare the foveal avascular zone measured in micrometer using OCT-A between both groups.
次要结局
- Compare the best corrected visual acuity in both groups(18 months total study duration , 9 months follow up)
- Compare incidence of macular edema in both groups.(18 months total study duration , 9 months follow up)
- Compare OCT ganglion cell complex (GCC) changes in both groups.(18 months total study duration , 9 months follow up)
- Compare incidence of epiretinal membrane formation in both groups.(18 months total study duration , 9 months follow up)
研究者
Ahmed Essam Faseeh
Assistant Lecturer of Ophthalmology
Kasr El Aini Hospital