Peri- Versus Intra-operative Anti-vascular Endothelial Growth Factor Intravitreous Injections for Diabetic Macular Edema in Patients Undergoing Cataract Surgery
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in best-corrected visual acuity (BCVA)
研究概览
简要总结
Goals of the study are to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how peri-operative versus intra-operative 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.
详细描述
Along with age, diabetes is a major risk factor for cataract formation, which can lead to significant vision loss and disability without medical intervention. Unfortunately, diabetic patients, particularly those with diabetic macular edema (DME), experience poorer visual outcomes after undergoing cataract surgery compared to non-diabetics. Reasons for this is multifactorial but includes an increased risk in the development of post-operative cystoid macular edema, and exacerbation of baseline DME. This poses a significant challenge in managing concomitant DME and visually-significant cataracts.
Goals of the study are to evaluate how peri-operative versus intra-operative anti-VEGF intravitreous injections affect visual acuity (BCVA) in patients with persistent diabetic macular edema who are undergoing cataract surgery; and to evaluate how peri-operative versus intra-operative 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
- None
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
Aflibercept injected Pre- and Post-operatively
Pre- and Post-operative time of Aflibercept injections
干预措施: Aflibercept injected Pre- and Post-operatively (Drug)
Aflibercept injected intraoperatively
Intraoperative time of Aflibercept injection
干预措施: Aflibercept injected intraoperatively (Drug)
结局指标
主要结局
Change in best-corrected visual acuity (BCVA)
时间窗: 1 month, 3 months and 6 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.
次要结局
- Change in optical coherence tomography (OCT) central subfield (CSF) thickness(24 hours post-operatively, 1 month, 3 months and 6 months after cataract surgery)
- Total number of postoperative injections(6 months after cataract surgery)
研究者
Andrew Hendrick
Principal Investigator
Emory University