The Effect of Pars Plana Vitrectomy Combined With Phacoemulsification Cataract Surgery in Phakic Diabetes Retinopathy Patients Over 45 Years Old: a Multicenter Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Best correct visual acuity
研究概览
简要总结
Pars plana vitrectomy (PPV) is one of the most widely used surgical therapies to proliferative diabetic retinopathy in the world.
However, as a predictable consequence of PPV surgery, postoperative cataract is observed in 79%-95% of phakic diabetes retinopathy patients after PPV in 6-24 months and a subsequent cataract surgery is usually required. While, the subsequent cataract surgeries not only bring additional economy and workload burden, but also increase the surgical risks. Since the two-step surgical approach has its defects, the combination of PPV and phacoemulsification is an ideal surgical option.
This study is a multi-center prospective study, aimed to evaluate the effect of PPV combined with phacoemulsification cataract surgery in phakic diabetes retinopathy patients, and make a comparation between the combined surgery and the two-step surgery in patients without severe lens opacities.
详细描述
The prevalence of diabetes retinopathy is increasing dramatically recent years. Pars plana vitrectomy (PPV) is one of the most widely used surgical therapies to proliferative diabetic retinopathy in the world.
However, as a predictable consequence of PPV surgery, postoperative cataract is observed in 79%-95% of phakic diabetes retinopathy patients after PPV in 6-24 months.Generally, subsequent cataract surgeries are required for the phakic patients within 6-16 months after the PPV surgery to improve visualization. While, the subsequent cataract surgeries not only bring additional economy and workload burden, but also increase the surgical risks because of the deep anterior chamber, zonular dehiscence, and inflammation. Since the two-step surgical approach has its defects, the combination of PPV and phacoemulsification is an ideal surgical option, which is only suggested in patients with severe lens opacities before the PPV surgery so far. For those with mild-moderate lens opacities, the benefits of combined surgery is unknown.
This study is a multi-center prospective study, aimed to evaluate the effect of PPV combined with phacoemulsification cataract surgery in phakic diabetes retinopathy patients, and make a comparation between the combined surgery and the two-step surgery in patients without severe lens opacities.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Proliferative diabetes retinopathy ;
- •Age over 45 years old;
- •mild-moderate lens opacities(LOCSⅢ : C3N3P3 or below);
- •recognition of at least one alphabet in ETDRS chart.
排除标准
- •Long-standing retinal detachment (more than three months), macular affected
- •Low Vision or blind on the other eye;
- •Macular degeneration, including age-related macular degeneration and Polypoidal choroidal vasculopathy;
- •Ocular trauma;
- •Hereditary retinopathy;
- •Severe lens opacities before the surgery (LOCSⅢ : C4N4P4 or above).
结局指标
主要结局
Best correct visual acuity
时间窗: Change from Baseline at 6 months after the surgery(s)
BCVA with ETDRS letters
Best correct visual acuity (BCVA)
时间窗: Change from Baseline at 1 week after the surgery(s)
BCVA with early treatment diabetic retinopathy study (ETDRS) letters
次要结局
- VFQ-25 score(Change from Baseline at 6 months after the surgery(s).)
- Treatment costs(through study completion, an average of 1 year)
- Complications(through study completion, an average of 1 year)
- Working delay time(through study completion, an average of 1 year)