Timing of Anti-vascular Endothelial Growth Factor（Anti-VEGF） Intravitreous Injections for Diabetic Macular Edema(DME) in Patients Undergoing Cataract Surgery
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in best-corrected visual acuity (BCVA)
研究概览
简要总结
The investigators aim to evaluate how different timing of anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with diabetic macular edema who are undergoing cataract surgery; and to evaluate how different timing of anti-VEGF intravitreous affect OCT CSF thickness and total number of postoperative injections in patients with diabetic macular edema who are undergoing cataract surgery.
详细描述
Cataract is very common in diabetic patients and can lead to significant vision loss and disability without medical intervention. Diabetic patients, particularly those with diabetic macular edema (DME), experience poorer visual outcomes after undergoing cataract surgery compared to non-diabetics. An increased risk in the development of post-operative cystoid macular edema and exacerbation of baseline DME is reported and this poses a significant challenge in managing concomitant DME and visually-significant cataracts.
Goals of the study are to evaluate how different timing of anti-VEGF intravitreous injections (before operation, intra-operation or after-operation) affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how different timing of anti-VEGF intravitreous injections affect OCT CSF thickness and total number of postoperative injections in patients with diabetic macular edema who are undergoing cataract surgery.
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 (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
- •Adults over age 18 with diabetes mellitus, diabetic macular edema and visually significant cataracts planning to undergo cataract surgery
排除标准
- •Patients who have undergone panretinal photocoagulation (PRP) in prior 4 months or an ocular condition (other than cataract and DME) that might affect visual acuity during course of study.
- •Patients with history of vitrectomy. Patients with neovascular glaucoma
研究组 & 干预措施
Lucentis injected Pre-operatively
Lucentis injected 2 weeks before cataract surgery
干预措施: Lucentis (Drug)
Lucentis injected intra-operatively
Lucentis injected during the course of the surgery by cataract surgeon.
干预措施: Lucentis (Drug)
Lucentis injected post-operatively
Lucentis injected 2 weeks after cataract surgery
干预措施: Lucentis (Drug)
结局指标
主要结局
Change in best-corrected visual acuity (BCVA)
时间窗: 1 month, 3 months , 6 months and 12 months after cataract surgery
BCVA is a measurement of the best vision correction that can be achieved, such as glasses, as measured on the standard Snellen eye chart. For example, if uncorrected eyesight is 20/200, but patient can see 20/20 with glasses, the BCVA is 20/20.
Change in optical coherence tomography (OCT) central subfield (CSF) thickness
时间窗: 24 hours post-operatively, 1 month, 3 months , 6 months and 12 months after cataract surgery
Optical coherence tomography (OCT) is an important imaging modality in the evaluation and management of retinal diseases. Change in central subfield (CSF) thickness will be measured and recorded.
次要结局
- Total number of postoperative injections(12 months after cataract surgery)
- percentage of patients with diabetic retinopathy progression(12 months after cataract surgery)
研究者
pandongyan
Principal Investigator
Second Military Medical University