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临床试验/CTRI/2019/08/020537
CTRI/2019/08/020537已完成1 期

COMPARISON OF ACCOMMODATION AND COLOR VISION AT VARIOUS LEVELS OF LED CORRELATED COLOR TEMPERATURES

Binu Sudheer2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年12月8日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
34
试验地点
2
主要终点
Accommodation-Dioptre, Time-Seconds,Color vision-Errors (number),Color Temperature-Kelvin

研究概览

简要总结

Testing of accommodation under various colour temperatures gives an idea about the reason behind the accommodation variation, setting up lighting Standards for a clinic , Pupil size change can be related to accommodation, Tunable LED light can be used for colour vision testing and for low vision patient (since it is color temperature tunable). (CCT-Correlated Color Temperature)

Accommodation- MEM Retinoscopy (Monocular estimation method), Negative relative accommodation and Positive relative accommodation, Minus lens method and pupil size is measured by Plus Optix Paediatric Autorefractometer. Color vision in Farnsworth D15 and Ishihara plates.

Adaptation Time- 5 Minutes , Lux level of 270 lux for farnsworth D15 test, Accommodation testing of 430 lux. Only CCTs which has highest CRI (Color Rendering Index) is selected for color vision testing and changes in accommodation is seen with respect to CRI ,SPD and CCT.

Here under each 6 lighting conditions, pupil size and accommodative response was measured. Then the other factors like Negative relative accommodation(NRA), Positive relative accommodation(PRA), Minus lens method was measured to prevent visual fatigue. Then at higher CRI (93,93,94) lightings of 5500K, 6500K and 8000K, the color vision testing was done. These were then analyzed using Repeated measures of ANOVA and Pair t test. Then the accommodation and pupil size change was compared with that of under natural light. The natural light measurement was done at MIT ground(Latitude-13.343581,Longitude- 74.794044)  . This then gives idea about the change in accommodative response.

Hypothesis testing:

a. Null hypothesis: There is no change in accommodation and color vision with respect to CCT variation

b. Alternate Hypothesis: There is a change in accommodation and color vision with respect to CCT variation

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • •1.Age 18 to 35 years 2.Not on any medications 3.No diplopia reported during the ocular motility test 4.Near point of convergence (RAF rule) ≤ 10cm 5.Amplitude of accommodation (push up RAF rule) normal for age (greater than 10D) 6.Stereo acuity (Titmus circles) of < 80 seconds of arc 7.Normal red/green colour vision (Ishihara) 8.Astigmatism of < 0.75DC 9.Visual acuity of at least 6/6 in each eye 10.Cover test of < 5Δ horizontal phoria and < 0.5Δ vertical phoria.

排除标准

  • ••Any known ocular pathology •Binocular vision anomalies •Systemic diseases affecting vision •Any colour vision defects •Migraine or history of migraine.

结局指标

主要结局

Accommodation-Dioptre, Time-Seconds,Color vision-Errors (number),Color Temperature-Kelvin

时间窗: 5 minutes after adaptation to light (Accommodation measurement), next intervals (1 minute accommodation relaxation time is given), then continued on between each intervals for accommodation. For color vision only adaptation time and no accommodation relaxation time.Total timing of 2 hours per subject.

次要结局

  • Pupil size-Millimeter,CRI-Color Rendering Index(Pupil size measurement is taken which is done immediately after 5 minutes adaptation time, CRI and color temperature is interrelated and is measured during the lighting setup.)

研究者

发起方
Binu Sudheer
申办方类型
Other [self]

研究点 (2)

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