Anatomical and Functional Outcomes of Use of Methotrexate Infusion and Intrasilicone Injection During Diabetic Vitrectomy
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- assess retinal layers by optical coherence tomography
研究概览
简要总结
The goal of this interventional clinical trial is to assess anatomical and functional outcomes of methotrexate use in irrigating fluid during parsplana vitrectomy combined with intrasilicone injection at end of surgery in patients with advanced proliferative diabetic retinopathy.
The main questions it aims to answer are:
- Does methotrexate use in irrigating fluid during parsplana vitrectomy combined with intrasilicone injection at end of surgery decrease the post operative vitreoretinal proliferation after vitrectomy in patients with advanced proliferative diabetic retinopathy?
- Does methotrexate use in irrigating fluid during parsplana vitrectomy combined with intrasilicone injection at end of surgery improve post operative functional outcome after vitrectomy in patients with advanced proliferative diabetic retinopathy?
Researchers will compare the anatomical and functional outcomes after vitrectomy in patients with advanced proliferative diabetic retinopathy without using methotrexate.
详细描述
Tractional macular detachment (TMD) or macula threatening tractional retinal detachment (TRD) and combined tractional-rhegmatogenous retinal detachment (TRD/RRD) are considered as important indications for vitreoretinal intervention.
Although a growing number of eyes with TMD and TRD/RRD are successfully treated with a single procedure, retinal re-detachment associated with fibrovascular proliferation or proliferative vitreoretinopathy (PVR) is still a major cause of failure of the surgery.
Previous studies have shown increased expression of inflammatory cytokines and growth factors in both proliferative diabetic retinopathy (PDR) and PVR.
Methotrexate (MTX) is an anti-neoplastic and anti-inflammatory agent used to treat a variety of malignancies and rheumatologic diseases.
In ophthalmology, systemic and intraocular MTX has been successfully used for indeterminate uveitis, sarcoid uveitis and intraocular lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Patients with diabetic tractional macular detachment or combined tractional- rhegmatogenous retinal detachment
排除标准
- •Previous vitreoretinal surgery.
- •Pregnant or lactating female.
- •Co-existing pathology that might induce PVR such as penetrating ocular trauma or uveitis, co-existing congenital anomalies or hereditary vitreoretinopathies
研究组 & 干预措施
Methotrexate group
methotrexate group will receive 40 mg of MTX in 500 ml of irrigation fluid during vitrectomy and 250 ug intra-silicone oil injection at the end of vitrectomy
干预措施: Methotrexate 25 MG/ML (Drug)
Methotrexate group
methotrexate group will receive 40 mg of MTX in 500 ml of irrigation fluid during vitrectomy and 250 ug intra-silicone oil injection at the end of vitrectomy
干预措施: parsplana vitrectomy (Procedure)
Control group
control group will not receive MTX in irrigation fluid during vitrectomy nor intra-silicone at the end of vitrectomy
干预措施: parsplana vitrectomy (Procedure)
结局指标
主要结局
assess retinal layers by optical coherence tomography
时间窗: one month after pars plana vitrectomy and one month after silicone oil evacuation
presence of epiretinal membrane, cystic changes in retina, central macular thickens
assess functional outcomes by multifocal electroretinogram
时间窗: one month after pars plana vitrectomy and one month after silicone oil evacuation
latency and amplitude of main P wave
次要结局
- Anterior segment slit lamp biomicroscopic examination(one month after pars plana vitrectomy)
- visual acuity(one month after pars plana vitrectomy and one month after silicone oil evacuation)
研究者
Abdallah Mohsen Mohamed Safwat
assistant lecturer, ophthalmology department, faculty of medicine
Minia University