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

NCT02854891 | Unknown DMC

• 1 other identifier: 0027:16
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myopia

Keywords

Effects; Heat; Light

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

• measurement of axial length

  change from baseline at the start point of the study, after 6 months and after 12 months

• measurement of Visual acuity

  change from baseline at the start point of the study, after 6 months and after 12 months.

• measurement of refraction

  change from baseline at the start point of the study, after 6 months and after 12 months.

• measurement of cornea curvature

  change from baseline at the start point of the study, after 6 months and after 12 months.

Interventions

autorefractometer, A-scan ultrasound OTHER

A measurement of refraction will be made by the Autorefractometer. A measurement of the eyes' biometer data will be made by A-scan ultrasound.

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Two hundred children at ages range from kindergarten to junior year of high-school (4-17), enrolled in the formal education system in hadera and it surrounding.

You may qualify if:

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

You may not qualify if:

• Noncooperative child or parents.
• Ocular surgery.
• Ocular genetic disease.

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: August 4, 2016
• Study Start: August 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: September 1, 2017
• Last Updated: August 4, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share