Ophthalmologic Evaluation of Patients With Obesity and Metabolic Syndrome Before and After Bariatric Surgery:A Pilot, Monocentric, Prospective, Open-label Study
试验速览
- 阶段
- 不适用
- 发起方
- XiaoYong Liu
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- optical coherence tomography
研究概览
简要总结
The aim of this study was to investigate the pathogenic role of obesity on blinding eye diseases in a population of severely obese patients with no history of eye diseases, and to verify whether weight loss induced by bariatric surgery may have a protective effect.
详细描述
This was a pilot, monocentric, prospective, and open label study conducted at First Affiliated Hospital of Jinan Universityreceived.Patients with body mass index ≥ 32.5Kg/m2; or patients with body mass index of 27.5-32.5Kg/m2 and metabolic diseases were consecutively recruited.All participants underwent complete ophthalmological evaluation， Keratograph 5M and optical coherence tomography.Patients who underwent bariatric surgery were evaluated also 3 months, 6 months and 1 year after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with BMI≥32.5Kg/m2；
- •patients with BMI27.5-32.5Kg/m2, combined with metabolic diseases;
排除标准
- •Patients with pre-existing ocular diseases or visual alterations were excluded to avoid confounding factors related to pre-existing retinal pathology, independent from obesity per se.
- •Patients with dementia, Parkinson's disease, Alzheimer's disease, multiple sclerosis or other severe neurological diseases were also excluded since ophthalmologic parameters may be altered in these conditions.
- •Patients with lens opacities that made impossible the posterior segment examination, or with a refractive error > +5 or <-8 diopters spherical equivalent were also excluded.
结局指标
主要结局
optical coherence tomography
时间窗: 12 months
次要结局
未报告次要终点
研究者
XiaoYong Liu
Deputy chief physician of opthalmology, The First Affiliated Hospital of Jinan University
First Affiliated Hospital of Jinan University