Effects of Hemodialysis on Intraocular Pressure in a University Hospital Located in Midwestern Brazil
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 主要终点
- assess changes in intraocular pressure (mmHg) before and after hemodialysis
研究概览
简要总结
Objective: To evaluate the variation in intraocular pressure in patients with chronic kidney disease, according to the time interval between hemodialysis sessions and to the influence of weight and blood pressure on intraocular pressure.
Methods: This was a cross-sectional study in which 78 eyes of 39 patients on hemodialysis, at the Santa Casa de Misericordia de Goiânia hospital, were analyzed in June 2014. Patients were divided into groups according to the days on which they underwent hemodialysis. The mean, standard deviation, and median of the intraocular pressure, blood pressure, and weight were calculated. P-values <0.05 were considered statistically significant.
详细描述
This cross-sectional observational study followed the guidelines of the Declaration of Helsinki, and all patients signed an informed consent form approved by the Ethics and Research Committee of the Pontifical Catholic University of Goiás (Pontifícia Universidade Católica de Goiás - PUC-GO). The inclusion criteria were chronic renal patients, who were older than 18 years of age, were part of the hemodialysis program of the Santa Casa de Misericordia de Goiânia (SCMG) hospital, signed the informed consent form and were able to undergo a physical examination. Exclusion criteria were patients on hemodialysis who were not chronic renal patients; patients who refused to participate in the study or could not undergo a physical examination; patients who did not undergo hemodialysis in the week of the study; prior ophthalmic eye disease or surgery; and patients allergic to anesthetic drops or dyes.
Patients were divided into groups according to the days on which they underwent hemodialysis. A total of 39 patients who were on hemodialysis at SCMG for six days in the month of June 2014 were analyzed. The patient's eye fundus was evaluated through direct ophthalmoscopy with a PanOptic device (Welch Allyn). Intraocular pressure was measured with a Kowa HA-2 Perkins applanation tonometer. The tonometry included three measurements in the central region of the cornea before and after hemodialysis. In all patients, the measurements were performed three times on the days when hemodialysis sessions were performed, with 24 hours between each session, and the means of the measurements were obtained. All parameters were measured under prior corneal anesthesia with 0.1% proparacaine and 0.25% fluorescein eye drops.
The variables studied were age, gender, base etiology for CKD, and variations in body weight and IOP before and after hemodialysis. Mean blood pressure (MBP), systolic blood pressure (SBP), diastolic blood pressure (DBP), and ocular perfusion pressure (OPP) were obtained before and after hemodialysis. The following mathematical models were used: MBP = (DBP) + 1/3 (SBP) - (DBP) and OPP = 2/3 (MBP-IOP), as described in the literature (18-20). The data were collected using a form devised for the study from the medical records of the chronic renal patients undergoing hemodialysis at SCMG and registered in the system.
The data were tabulated in a Microsoft© Excel 2007 spreadsheet and analyzed using the Statistical Package for the Social Sciences, version 20 (SPSS, Chicago, IL). The mean, standard deviation, median IOP measurements, blood pressure, and weight were obtained. Data normality was assessed by the Kolmogorov-Smirnov test. The significance of differences between measurements obtained before and after hemodialysis was assessed by the Wilcoxon test. The relationship between IOP and weight was assessed by Pearson's or Spearman's correlation. P-values <0.05 were considered significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic renal patients
- •Patientes signed the informed consent form and were able to undergo a physical examination
- •Patients between 18-75 years of age
排除标准
- •Patients with chronic eye disease and / or eye surgery
- •Patients allergic to anesthetic drops or dyes.
- •Patients who had no physical condition to the eye examination
- •Patients who refused to participate in the study
结局指标
主要结局
assess changes in intraocular pressure (mmHg) before and after hemodialysis
时间窗: baseline (before hemodialysis ) and end of hemodialysis ( four hours late)
次要结局
未报告次要终点
研究者
Rodrigo Egidio da Silva
ophthalmologist
VER Excelência em Oftalmologia
