NCT01733550Unknown不适用
ICare Self-tonometry - A Head-to-head Comparison to the Gold Standard Goldmann Tonometer
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Intra-ocular pressure with Home ICare and Goldmann Applanation Tonometer.
研究概览
简要总结
The purpose of this study is to compare glaucoma patients' own I Care measurements by the standard Goldmann applanation tonometer intraocular pressure (IOP) measurements.
详细描述
not necessary
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Ocular hypertension (OHT):with/without glaucoma drugs
- •Primary open angle glaucoma (POAG)- high pressure: Diagnosis based on optic nerve head rim loss and/or visual field defects and intraocular pressure (IOP) >21 mmHg.
- •Primary open angle glaucoma, normal pressure: cfr high pressure but intraocular pressure ≤ 21 mmHg
- •Exfoliative Glaucoma (PEX): Diagnosis based on optic nerve head rim loss and/or visual field defects and intraocular pressure (IOP) >21 mmHg, with exfoliation material in the anterior segment.
- •Pigmentary Glaucoma (PDG): Diagnosis based on optic nerve head rim loss and/or visual field defects and intraocular pressure (IOP) >21 mmHg, with Krukenberg's spindle and/or pigment dispersed on the trabecular meshwork.
排除标准
- •Age <18 years
- •Other glaucoma types
- •Corneal pathology (edema, dystrophia, corneal transplantation, severe keratoconus, permanent contact lens wear, recurrent corneal erosion)
- •Severe arthritis (unable to handle home i care device)
- •Lack of comprehension
- •Intra ocular surgery and laser treatment during the last 6 months
结局指标
主要结局
Intra-ocular pressure with Home ICare and Goldmann Applanation Tonometer.
时间窗: immediate comparison, no time frame required
Patients eye pressure measurement with both devices. 1. Home ICare measurement by study nurse compared to Home ICare by patient compared to Goldmann ATO by study nurse (once for every patient) 2. 4 times daily: measurement Goldmann ATO (by resident in ophthalmology) and home Icare (by patient)on same moment
次要结局
- Patient Comfort(1 day hospitalisation)
研究者
研究点 (1)
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