UCST Studie 1 - Jämförande Studie Mellan några Befintliga Och Nyutvecklade Metoder för Att mäta Den Spektrala kontrastkänslighetsfunktionen Hos människa
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Average area under the curve for the log contrast sensitivity function (AULCSF) in one eye for each method
研究概览
简要总结
This study evaluates the relative performance of different methods to measure the human spectral contrast sensitivity function (CSF).
详细描述
The human spectral contrast sensitivity function (CSF) is a better way to estimate human vision than letter charts commonly used by ophthalmologists, optometrists and opticians.
The current methods used to measure the CSF are often unreliable, due to high variability between measurements. This study will compare four (4) new tests with two (2) currently used standard tests. The contrast sensitivity function will be measured using all of the six (6) methods three times (3) in each of the two (2) eyes at two (2) occasions. Each subjects CSF will be measured 6x3x2x2 = 72 times.
In addition, for each of the CSF measurements, the time used to measure the CSF and number of background variables for the subjects will be recorded.
After informed consent is obtained, the subjects will undergo a visual examination. If they match the inclusion criteria they will be included. At that time or at their earliest possible convenience, their CSF will be measured using the six methods and some background information will be recorded.
The follow-up measurement occasion will occur between 4 to 6 weeks (28 to 42 days) after the first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Normal best corrected visual acuity: LogMAR = 0
- •No current or previous eye disease in either eye.
- •Student at Uppsala University
排除标准
- •Previous surgery in any eye
- •Inability to follow the test procedure.
研究组 & 干预措施
UCST-V1
The UCST-V1 contrast sensitivity test, used to measure CSF thrice in each eye at two occasions in every treatment sequence (multi-period crossover)
干预措施: UCST-V1 (Device)
UCST-V2
The UCST-V2 contrast sensitivity test, used to measure CSF thrice in each eye at two occasions in every treatment sequence (multi-period crossover)
干预措施: UCST-V2 (Device)
UCST-V3
The UCST-V3 contrast sensitivity test, used to measure CSF thrice in each eye at two occasions in every treatment sequence (multi-period crossover)
干预措施: UCST-V3 (Device)
Quick-CSF
The Quick-CSF test, used to measure CSF thrice in each eye at two occasions in every treatment sequence (multi-period crossover)
干预措施: Quick-CSF (QCSF) (Device)
Pelli-Robson
The Pelli-Robson contrast sensitivity test, used to measure CSF thrice in each eye at two occasions in every treatment sequence (multi-period crossover)
干预措施: Pelli-Robson (Device)
Optec 6500
The Optec 6500 contrast sensitivity test, used to measure CSF thrice in each eye at two occasions in every treatment sequence (multi-period crossover)
干预措施: Optec 6500 (Device)
结局指标
主要结局
Average area under the curve for the log contrast sensitivity function (AULCSF) in one eye for each method
时间窗: At end of data collection (up to 12 months after first subject is included)
The area-under-curve of the LCSF, calculated from the measured CSF.
Average time (in seconds) used to measure the contrast sensitivity function for one eye for each method
时间窗: At end of data collection (up to 12 months after first subject is included)
次要结局
- Sources of variability of the average area under the curve for the log contrast sensitivity function [AULCSF squared](At end of data collection (up to 12 months after first subject is included))
- Sources of variability of the average time used to measure the contrast sensitivity function [seconds squared](At end of data collection (up to 12 months after first subject is included))