Ambient Light Levels in the Kindergarten and Schools and the Relation to Refractive Development

• Conditions: Myopia

• Registration Number: NCT02854891
• Lead Sponsor: Hillel Yaffe Medical Center

Brief Summary

Myopia, the most common human eye disorder, is a phenomenon characterized by an unconstrained elongation of the eye globe There are number of theories concerning the environmental effect on the emmetropization process, most are related to childhood exposure to outdoor activity, near work and sleep with night light. Studies in lab animals found an association between intensity of ambient lighting and myopia development.

In this study, the investigators will examine the ambient light in kindergarten and schools and their relation to refractive error. Diurnal luminance in kindergarten and school class room will be measured and correlated to biometric measures such as refraction, axial length and keratometry.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-03
• Study First Submitted: 2016-03-21
• Study First Submitted QC: 2016-07-31
• Last Update Submitted: 2016-07-31
• Study Start: 2016-08
• Study First Posted: 2016-08-04
• Last Update Posted: 2016-08-04
• Primary Completion: 2017-02
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the relation between the level of myopia and light intensity	change from baseline at the start point of the study, after 6 months and after 12 months	an analysis of the correlation between the two variables. the data will be collected as reported in the secondary outcome measures (number 2 and 5).

Secondary Outcome Measures

Name	Time	Method
levels of ambient light intensity	natural light- start of study and once a month until completion, average of 1 year. artificial light- once at the start point of the study	Classes that are influenced by sunlight will be examined for light levels at a specific day of each month . For classes that are not influenced by sunlight, light source and levels will be documented. the measurement will be held until study completion.; will be measured by luxmeter. the results will be in LUX (standardised unit of measurement of light intensity)
measurement of axial length	change from baseline at the start point of the study, after 6 months and after 12 months	will be measured using A-scan ultrasound. the results will be in millimeters.
measurement of Visual acuity	change from baseline at the start point of the study, after 6 months and after 12 months.	will be measured using LogMAR chart.
measurement of refraction	change from baseline at the start point of the study, after 6 months and after 12 months.	will be measured using autorefractometer. the results will be in diopter
measurement of cornea curvature	change from baseline at the start point of the study, after 6 months and after 12 months.	will be measured using autorefractometer. the results will be in millimeters.