Management of Patients With Neovascular Age-related Macular Degeneration Undergoing Cataract Surgery: A Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Visual acuity change from baseline
研究概览
简要总结
To-date there have been only very few studies to examine the effect of cataract surgery to patients with wet age-related macular degeneration. The evidence on the effects of cataract surgery in such patients suggests improvement of their visual function and quality of life, but at the same time a subclinical susceptibility to macular edema and exacerbation of the choroidal neovascularization. Therefore it is highly important to identify the optimum treatment regime, pursuing the best anatomical and functional postoperative results.
详细描述
To-date there have been only very few studies to examine the effect of cataract surgery to patients with neovascular age-related macular degeneration (AMD), especially in the era of anti-vascular endothelial growth factor (anti-VEGF) therapy. Furthermore the issue of optimum treatment regimen that should be used in the peroperative period has never been addressed. Since the human life expectancy gradually increases, the number of patients who are under anti-VEGF intravitreal injections for wet AMD will be increasing accordingly. Cataract surgery in such patients, despite guarded prognosis has been proved to improve their visual function and quality of life. On the other hand, it has been shown that cataract surgery induces anatomic changes based on optical coherence tomography analysis, suggesting a subclinical susceptibility to postoperative cystoid macular edema or exacerbation of choroidal neovascularization. Therefore it is highly important to identify the optimum treatment regime, pursuing the best anatomical and functional postoperative results.
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
- 50 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active choroidal neovascularization (at least 1 intravitreal injection in the past 12 months) associated with AMD and involving the foveal center
- •BCVA of 1.0 (LogMAR) or better
- •Duration of wet AMD less than 3 years
排除标准
- •Coexisting ocular pathology potentially affecting visual acuity and/or status of the macula including diabetic retinopathy, advanced glaucoma, retinal vein occlusion, retinal detachment
- •Newly diagnosed patients with wet AMD who are on anti-VEGF treatment for less than 6 months
研究组 & 干预措施
Intensive Treatment
The participants will receive x1 intraoperative and 3 postop monthly injections. Subsequently, they will follow the treat and extend protocol.
干预措施: Ranibizumab (Drug)
Standard Treatment
The participants will continue their preoperative treat and extend protocol .
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Visual acuity change from baseline
时间窗: 12 months
Difference in visual acuity change from baseline at the end of the follow-up period.
Difference in the number of injections
时间窗: 12 months
Difference in the number of injections at the end of the follow-up period.
次要结局
- Status of the macular degeneration based on optical coherence tomography parameter, as compared to baseline(12 months)