Comparison of Visual Outcomes of Pars Plana Vitrectomy With and Without Injection Clexane for Rhegmatogenous Retinal Detachment Proliferative Vitreoretinopathy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 主要终点
- Postoperative Visual Acuity
研究概览
简要总结
This interventional prospective study was conducted in the Department of Ophthalmology at Lahore General Hospital, Lahore. The study included 60 male and female patients aged 18-65 years who had rhegmatogenous retinal detachment associated with grade C proliferative vitreoretinopathy (PVR) and who met the predefined eligibility criteria.
All participants underwent pars plana vitrectomy (PPV) for retinal detachment repair. Participants were treated either with enoxaparin sodium (Clexane) added during surgery or with the same surgical procedure without enoxaparin sodium. The study was designed to determine whether the use of enoxaparin sodium during PPV could improve postoperative visual outcome compared with PPV performed without enoxaparin. Enoxaparin was evaluated because of its anticoagulant and anti-inflammatory properties and its possible role in reducing postoperative inflammatory changes associated with proliferative vitreoretinopathy.
Visual acuity was assessed before surgery and after surgery using a Snellen visual acuity chart. Relevant demographic and clinical information, ophthalmic examination findings, diagnosis, surgical procedure, preoperative visual acuity, postoperative visual acuity, and treatment outcome were recorded. The main comparison between the two study groups was the postoperative visual acuity following pars plana vitrectomy with versus without intraoperative enoxaparin sodium.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 18-65 years.
- •Rhegmatogenous retinal detachment with grade C proliferative vitreoretinopathy in the study eye.
- •Patients with a clear crystalline lens or pseudophakia in the study eye.
排除标准
- •Giant retinal tear in the study eye measuring more than 3 clock hours.
- •Patients scheduled for combined pars plana vitrectomy and cataract surgery for retinal detachment repair in the study eye.
- •Chronic inflammatory condition involving the study eye.
- •History of perforating or non-perforating ocular trauma in the study eye.
- •Cataract surgery within the preceding 3 months in the study eye.
- •Previous retinal procedures in the study eye within the preceding 6 months, including laserpexy, cryopexy, intravitreal gas injection, anti-vascular endothelial growth factor injection, or corticosteroid injection.
- •Single-eyed patients, defined in the synopsis as having best-corrected visual acuity in the fellow eye of >1.0 logMAR, <0.1 decimal, <1/10, or <6/60 Snellen fraction.
结局指标
主要结局
Postoperative Visual Acuity
时间窗: 3 months after surgery
Postoperative distance visual acuity was assessed using a Snellen visual acuity chart and compared between participants undergoing pars plana vitrectomy with intraoperative enoxaparin sodium and those undergoing pars plana vitrectomy without enoxaparin sodium.
次要结局
未报告次要终点
研究者
Muhammad Irfan Jamil
Principal Investigator
Lahore General Hospital