Methotrexate as an Adjunct to Parsplana Vitrectomy for the Preventing and Treatment of Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment: A Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Visual Acuity
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of intraocular methotrexate (MTX) in preventing and managing proliferative vitreoretinopathy (PVR) in patients undergoing retinal detachment surgery
详细描述
Patients will be randomized into two groups if clinical evidence of PVR is detected at the time of surgery, utilizing a computer-generated list for randomization. All surgeries will be conducted by the same surgeon to maintain consistency in technique.
Intervention Groups:
- Group 1 (PPV Alone): Patients in this group will undergo pars plana vitrectomy (PPV) only.
Group 2 (PPV with Methotrexate): Patients in this group will receive complete PPV along with adjunctive intravitreal methotrexate.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and older.
- •Diagnosed with RRD with clinical signs of PVR.
- •No history of prior ocular surgeries for RRD or PVR.
排除标准
- •Patients with other retinal diseases (e.g., diabetic retinopathy or retinal vascular occlusions).
- •Individuals with significant systemic illnesses that could influence surgical outcomes.
结局指标
主要结局
Visual Acuity
时间窗: 3 and 6 months after tamponade removal
Best-Corrected Visual Acuity (BCVA): BCVA will be measured using the logarithm of the minimum angle of resolution (LogMAR) scale. A LogMAR value of 0.0 corresponds to normal visual acuity (Snellen equivalent 6/6 or 20/20), representing the ability to resolve an optotype that subtends 5 minutes of arc. Visual acuity will be converted to LogMAR values for statistical analysis.
Anatomical Success
时间窗: within 6 months after tamponade removal
Successful Retinal Reattachment: Defined as complete reattachment of the neurosensory retina to the underlying retinal pigment epithelium (RPE) without persistent or recurrent subretinal fluid at the final follow-up visit, as confirmed by clinical examination and optical coherence tomography (OCT), in the absence of tamponade or additional surgical intervention.
Number of Operations Required
时间窗: within 6 months after tamponade removal
The total number of surgical procedures (including vitrectomy, scleral buckling, retinopexy, or tamponade exchange) required to achieve and maintain retinal reattachment will be recorded for each eye.
次要结局
未报告次要终点
研究者
Ehab Mohamed Elsayed Mohamed Saad
Lecturer
Benha University