Study of Test-retest Reliability of Dynamic Contour Tonometry and Its Correlation With Goldmann Applanation Tonometry
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- IOP expressed in mmHg
研究概览
简要总结
Study wants to test reliability Dynamic Contour Tonometry (DCT) in measuring intraocular pressure (IOP) and Ocular Pulse Amplitude (OPA). IOP values obtained with DCT will then be compared with IOP values obtained with Goldmann Applanation Tonometry (GAT), actually the gold standard technique.
详细描述
Healthy volunteers recruited among subjects who underwent a routine ophthalmologic evaluation or among students and workers both at our clinic, will undergo a series of 5 DCT to evaluate eventual differences among the measurements.
A diurnal IOP curve performed though GAT, composed of 3 measurements (9am, noon, 4pm) will be taken 1 to 7 days before the DCT.
At the end of the DCT measurements a last GAT will be taken to control eventual IOP changes versus previous GAT values obtained through the diurnal curve.
After 3 weeks observers will contact patients to record eventual adverse events. If examiners consider it as necessary, a safety ophthalmological evaluation will then be performed.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy subjects giving a valid consent to be included in this experimentation
- •age between 18 and 80 years
- •best corrected visual acuity (BCVA) of at least 20/100
- •refraction ranging from -6 to +6 dioptres, with an astigmatism ranging from -2 to +2 dioptres
排除标准
- •History of refractive surgery or any keratoplasty procedure.
- •Corneal opacities or diseases making no suitable applanation tonometry.
- •Use of contact lenses. History of glaucoma or ocular hypertension.
- •History of diabetic retinopathy staged as severe non-proliferative or worse.
结局指标
主要结局
IOP expressed in mmHg
时间窗: measurements will be taken in a single day, in approximately 30 minutes.
5 consecutive valid DCT measurements will be taken. After test-retest reliability of these DCT measurements will then be calculated (difference expressed in mmHg between 1st and 5th DCT measurements of IOP. Coefficient of Variation will also be calculated).
OPA expressed in mmHg
时间窗: measurements will be taken in a single day, in approximately 30 minutes.
5 consecutive valid DCT measurements will be taken. After test-retest reliability of these DCT measurements will then be calculated (difference expressed in mmHg between 1st and 5th DCT measurements of OPA. Coefficient of Variation will also be calculated).
次要结局
- IOP difference (expressed in mmHG) between first GAT and DCT(partecipants will undergo a GAT diurnal tonometric curve (one day duration) and after one to seven days will undergo 5 DCT (approx. duration 30 minutes))
- IOP difference (expressed in mmHG) between DCT and last GAT(partecipants will undergo 5 DCT and after these, to a single GAT measurement(approx. duration 30 minutes))
研究者
Luigi Varano, MD - Principal Investigator
M. D.
University of Catanzaro