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

Sponsor
Hillel Yaffe Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02854891
Collaborator
(none)
200
13

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: autorefractometer, A-scan ultrasound

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Ambient Light Levels in the Kindergarten and Schools and the Relation to Refractive Development
Study Start Date :
Aug 1, 2016
Anticipated Primary Completion Date :
Feb 1, 2017
Anticipated Study Completion Date :
Sep 1, 2017

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)

  2. 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.

  3. 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.

  4. 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

  5. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hillel Yaffe Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT02854891
Other Study ID Numbers:
  • 0027:16
First Posted:
Aug 4, 2016
Last Update Posted:
Aug 4, 2016
Last Verified:
Mar 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Hillel Yaffe Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 4, 2016