Project Gullstrand - European Project for the Determination of Average Biometric Values of Human Eyes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,646
- 试验地点
- 1
- 主要终点
- To obtain a predetermined number of valid visual function measurements per participating site
研究概览
简要总结
The purpose of this study is to determine the average values of human ocular biometry and to correlate these values with visual function.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Two normal eyes
- •Ametropia between -10D and +10D.
排除标准
- •One pathological eye
- •Prior ocular surgery
- •Amblyopia, refraction larger than ±10D
- •Corneal or retinal pathologies
- •Systemic diseases (e.g. diabetes, multiple sclerosis, ...)
- •More than 5 months pregnant at the moment of testing
- •Recent wear of hard contact lenses
- •Epilepsy (if C-Quant is used).
结局指标
主要结局
To obtain a predetermined number of valid visual function measurements per participating site
时间窗: 19 months
The tests that will be performed are the eye dominance, accommodation, uncorrected and spectacle corrected visual acuity (UCVA and SCVA), ocular refraction (automatic refraction), spectacle refraction, axial length (optical, ultrasound), anterior segment biometry (anterior chamber depth), corneal topography (keratometry), contrast sensitivity (Pelli-Robson/ Sine Wave Contrast Test (SWCT)), intraocular pressure, the VFQ-25 questionnaire and some demographic data (age, gender, ethnicity, eye color, highest education).
to obtain a predetermined number of valid ocular biometry measurements per participating site
时间窗: 19 months
The test that will be performed are the eye dominance, uncorrected and corrected distance visual acuity (UDVA and CDVA), (accommodation, ocular refraction (automatic refraction), spectacle refraction, axial length (optical, ultrasound), anterior segment biometry (anterior chamber depth), corneal topography (keratometry), contrast sensitivity (Pelli-Robson/ Sine Wave Contrast Test (SWCT), pupil size (gauge)), intraocular pressure, the VFQ-25 questionnaire and some demographic data (age, gender, ethnicity, eye color, highest education).
次要结局
- Provide a reference database for research purposes(19 Months)