Comparison of the Effect of Tropicamide 0.5% and Tropicamide 1% on Intraocular Pressure, Pupil Size, Keratometry and Anterior Chamber Parameters in Patients With Type 1 and Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Change from baseline in Intraocular pressure (IOP)
研究概览
简要总结
The aim of this study is to compare the effect of tropicamide 0.5% and tropicamide 1% on intraocular pressure and anterior chamber parameters in patients with Diabetes Mellitus.
详细描述
Patients with diabetes type 1 and type 2 older than 21 years of age, in the specialized clinic of Kowsar Hospital (Semnan University of Medical Sciences) are examined. Eligible individuals enter the study and are randomly assigned to group 1 or group 2. In each group, visual acuity measurement, slit lamp biomicroscopy and fundus examination are performed. Intraocular pressure is measured with Goldmann applanation tonometer. pupil size, refraction and keratometry are measured with two different autorefractokeratometers. keratometry, pupil size and other anterior chamber parameters are also evaluated by Oculus Pentacam imaging. Then, the patients receive tropicamide 0.5% drops in group 1 and tropicamide 1% drops in group 2. 30 minutes later, all previous measurements are repeated. Patients and the ophthalmologist and the data analyzer are unaware of the drug type.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The drops are instilled into the patients' eye by a nurse. Study participants are unaware of the type of medication used. The outcome assessor (ophthalmologist) does not know the type of medication used for each patient. The data is analyzed by an biostatistician. He or she also does not know the type of drug used for each patient.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Diabetes Mellitus type 1 and 2
排除标准
- •Proliferative diabetic retinopathy
- •History of cataract surgery
- •severe nuclear and cortical cataract
- •Intraocular pressure (IOP) greater than 21 mmHg
- •Familial history of glaucoma
- •Narrow angle (Van Herick 1, 2)
- •Cup to disc ratio greater than 0.5
- •Pregnancy
- •Pterygium
- •Corneal ectasia
- •History of keratorefractive surgery
- •Corneal dystrophy
- •Iris disorders
- •Anisocoria
- •Iris neovascularization
- •Use of miotics or mydriatics
研究组 & 干预措施
Tropicamide 0.5%
This group receives tropicamide 0.5% (one drop every 5 minutes for 2 times) drops.
干预措施: Tropicamide Ophthalmic (Drug)
Tropicamide 1%
This group receives tropicamide 1% (one drop every 5 minutes for 2 times) drops.
干预措施: Tropicamide Ophthalmic (Drug)
结局指标
主要结局
Change from baseline in Intraocular pressure (IOP)
时间窗: Before intervention, 30 minutes after intervention
The intraocular pressure is measured by Goldmann applanation tonometry
Change from baseline in pupillary diameter
时间窗: Before intervention, 30 minutes after intervention
The diameter of the participants' pupil is measured by Scheimpflug camera (Oculus Pentacam); Autorefractokeratometer (TOMEY RC-5000 and Topcon KR-1)
次要结局
- Change from baseline in anterior chamber angle (ACA)(Before intervention, 30 minutes after intervention)
- Change from baseline in central corneal thickness (CCT)(Before intervention, 30 minutes after intervention)
- Change from baseline in Keratometry(Before intervention, 30 minutes after intervention)
- Change from baseline in anterior chamber depth (ACD)(Before intervention, 30 minutes after intervention)
- Change from baseline in anterior chamber volume (ACV)(Before intervention, 30 minutes after intervention)
研究者
Navid Elmi Sadr
Assistant professor of ophthalmology
Semnan University of Medical Sciences