NCT00837226撤回不适用
The Effects of Weight Loss From Bariatric Surgery on Intraocular Pressure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Intraocular pressure
研究概览
简要总结
The purpose of this study is to determine if there is an effect on the eye pressure from extreme weight loss by bariatric procedures. The hypothesis is that excess fat in the orbit of the eye compresses on the outflow system, which causes an elevated eye pressure. This can have many consequences, including the risk for glaucoma. We hope to establish if there is an effect between eye pressure and weight.
研究设计
- 研究类型
- Observational
- 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
- •Written informed consent obtained
- •BMI > 40 kg/m2 without associated comorbidities or > 35 kg/m2 with associated comorbidities. In the normal indication for routine bariatric surgery, comorbidities include hypertension, type II diabetes, venous stasis, sleep apnea, polycystic ovary syndrome, pseudotumor cerebri, nonalcoholic steatohepatitis, gastroesophageal reflux disease, coronary artery disease, degenerative joint disease, cancer, and hypercholesterolemia.
排除标准
- •Current use of systemic steroids
- •Any systemic medication which is unstable and can affect IOP
- •History or evidence of glaucoma
- •Any ocular trauma or ocular surgery
- •Outside normal range of corneal thickness (500-600 microns)
- •Unable to follow-up for 3 years
- •Participating in any investigational device or medication study within 30 days of baseline
结局指标
主要结局
Intraocular pressure
时间窗: Data will be recorded the same day when a patient comes to the clinic.
次要结局
未报告次要终点
研究者
Robert Feldman
◦Clinical Professor and Chair and Richard S. Ruiz, M.D., Distinguished University Chair in Ophthalmology
The University of Texas Health Science Center, Houston
研究点 (1)
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