JPRN-jRCTs042230066招募中未知
Exploratory study of 24-hour intraocular pressure fluctuation profile in patients with primary open-angle glaucoma and healthy subjects with contact lens sensor
Higashide Tomomi0 个研究点目标入组 150 人开始时间: 2023年8月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 80age old（—）
- 性别
- All
入选标准
- •1)Subjects of male or female over 20 to 79 years old
- •2)Patients with primary open-angle glaucoma who have been followed up for 2 years or more at the medical in-stitution, or patients who have been diagnosed with primary open-angle glaucoma for the first time, or healthy subjects who have no findings suggesting glaucoma and have no other eye disease.
- •3)Signed informed consent for the investigation
排除标准
- •1) Patients with a static visual field testing (HFA 30-2 or 24-2 program) MD value of -12.0 dB or less in the study eye
- •2) The spherical diopter of the inspected eye is plus minus 6.00D, and the cylinder diopter is out of the range of plus minus 3.00D
- •3) In addition to glaucoma, existence with another eye diseases that affect the results of visual field testing and three-dimensional fundus image analysis using optical coherence tomography in the study eye
- •4) Glaucoma surgery, glaucoma laser treatment, refractive surgery within 6 months before the start of the study
- •5) Allergy to corneal anesthetic
- •6) Patients with implanted cardiac pacemakers or other electro-medical devices
- •7) Patients with eye infections
- •8) Patients with acute and subacute inflammation of the anterior segment of the eye
- •9) Patients with corneal, conjunctival, or eyelid abnormalities,corneal hypoesthesia, lacrimal insufficiency, or tear secretion insufficiency, or lacrimal disease to the extent that it affects the use of the sensor.
- •10) Patients with a history of complications related to contact lens wear
- •11) Patients with allergic diseases to silicone materials
- •12) Any person who is in an environment where the sensor is contaminated by spray, smoke, dust, steam, etc.
- •13) Patients with complications such as serious cardiac, hepatic, renal, pulmonary, or hematological diseases that are considered unsuitable for clinical research.
- •(14) Those who have participated in other clinical research or clinical trials (including those outside the field of ophthalmology) within the past six months.
- •(15) Any other person whom the principal investigator or subphysician determines to be unsuitable for the subject, or who the principal investigator or sub-physician determines to be unsuitable for wearing contact lenses
研究者
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