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

July 31, 2016 updated by: Hillel Yaffe Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the relation between the level of myopia and light intensity
Time Frame: 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).
change from baseline at the start point of the study, after 6 months and after 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
levels of ambient light intensity
Time Frame: 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)
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
Time Frame: 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.
change from baseline at the start point of the study, after 6 months and after 12 months
measurement of Visual acuity
Time Frame: change from baseline at the start point of the study, after 6 months and after 12 months.
will be measured using LogMAR chart.
change from baseline at the start point of the study, after 6 months and after 12 months.
measurement of refraction
Time Frame: 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
change from baseline at the start point of the study, after 6 months and after 12 months.
measurement of cornea curvature
Time Frame: 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.
change from baseline at the start point of the study, after 6 months and after 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

March 21, 2016

First Submitted That Met QC Criteria

July 31, 2016

First Posted (Estimate)

August 4, 2016

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

July 31, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0027:16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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