Assessing the Impact of Diabetes Mellitus on Anterior Chamber Cytokine Production and Postoperative Macular Edema in Patients Undergoing Femtosecond Laser-assisted Cataract Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Aqueous humor concentrations of inflammatory mediators at the onset of manual cataract surgery and following femtosecond laser treatment
研究概览
简要总结
The purpose of this study is to assess the effects of diabetes mellitus (DM) on anterior chamber cytokine production and postoperative macular edema in patients undergoing femtosecond laser-assisted cataract surgery (FLACS). Patients with DM routinely undergo FLACS, yet the majority of studies evaluating intraocular inflammation following femtosecond laser treatment have excluded this patient population. Importantly, DM alters the inflammatory status of the eye, which may influence the production of inflammatory mediators following femtosecond laser treatment and the development of postoperative macular edema. The results from this study will provide insight into the risks and benefits of FLACS in patients with DM.
详细描述
As discussed above.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients who are scheduled for manual cataract surgery or FLACS who have provided informed consent, in accordance with application regulations and guidelines.
- •Only one eye from each participant will be included in the study (the first one to be operated on).
排除标准
- •Intravitreal anti-VEGF injection < 3 months prior to cataract surgery
- •Laser photocoagulation < 3 months prior to cataract surgery
- •Complications during manual cataract surgery or FLACS
- •Current or previous ocular or systemic inflammation
- •History of rheumatic or immune disease
- •Poor pharmacologic mydriasis
- •Corneal opacities
- •Pseudoexfoliation syndrome
- •Previous ocular surgery or trauma
- •Use of topical or systemic steroids < 6 months prior to surgery
- •Prostaglandin analog eyedrop therapy
- •Age-related macular degeneration
结局指标
主要结局
Aqueous humor concentrations of inflammatory mediators at the onset of manual cataract surgery and following femtosecond laser treatment
时间窗: 1 day
Cytokine concentration at time of cataract surgery
次要结局
- Postoperative change in macular volume(Post op day 1, week 1, month 1 and month 3)
- Microvascular changes and development of cystic macular lesions(Post op day 1, week 1, month 1 and month 3)
- Best corrected visual acuity(Post op day 1, week 1, month 1 and month 3)
- Prevalence and severity of postoperative flare(Post op day 1, week 1, month 1 and month 3)
- Prevalence of postoperative macular edema in control and diabetic participants(Post op day 1, week 1, month 1 and month 3)
- Postoperative change in central retinal thickness(Post op day 1, week 1, month 1 and month 3)