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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02854891
• Other study ID #: 0027:16
• Status: Not yet recruiting
• Phase: N/A
• First received: March 21, 2016
• Last updated: July 31, 2016
• Start date: August 2016
• Est. completion date: September 2017

Study information

• Verified date: March 2016
• Source: Hillel Yaffe Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 17 Years

Eligibility

Inclusion criteria

• Every child that have been studying in the same class for the last 6-12 months (kindergarten and school respectively).

Exclusion criteria

• Noncooperative child or parents.

• Ocular surgery.

• Ocular genetic disease.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Myopia

Intervention

Other:
• autorefractometer, A-scan ultrasound
A measurement of refraction will be made by the Autorefractometer. A measurement of the eyes' biometer data will be made by A-scan ultrasound.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the relation between the level of myopia and light intensity	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).	change from baseline at the start point of the study, after 6 months and after 12 months	No
Secondary	levels of ambient light intensity	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)	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	No
Secondary	measurement of axial length	will be measured using A-scan ultrasound. the results will be in millimeters.	change from baseline at the start point of the study, after 6 months and after 12 months	No
Secondary	measurement of Visual acuity	will be measured using LogMAR chart.	change from baseline at the start point of the study, after 6 months and after 12 months.	No
Secondary	measurement of refraction	will be measured using autorefractometer. the results will be in diopter	change from baseline at the start point of the study, after 6 months and after 12 months.	No
Secondary	measurement of cornea curvature	will be measured using autorefractometer. the results will be in millimeters.	change from baseline at the start point of the study, after 6 months and after 12 months.	No