Impact of Electronic Devices on Myopia Development and Progression

Myopia Clinical Trial

Official title:

Impact of School Curriculum Engaging Electronic Devices on Myopia Development and Progression in Primary Schoolchildren

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02150421
• Other study ID #: TWGHs
• Secondary ID: TWGHs2013
• Status: Completed
• Phase: N/A
• First received: May 26, 2014
• Last updated: June 21, 2016
• Start date: September 2013
• Est. completion date: February 2016

Study information

• Verified date: June 2016
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The aim of the stuy is to investigate the effects of the adoption of a curriculum with electronic devices for teaching materials and textbooks in Hong Kong schoolchildren on their changes in refractive error and visual function.

Description:

With the blooming of information technology and electronic engineering in recent years, e-books or tablet computers have been introduced at some local primary and secondary schools and have been provided for their students during studying at school and at home. Parents and teachers' utmost concern are adverse effects on eye-sight of children, especially the higher progression rate in myopia and the visual discomfort which may be caused by the e-book technology.

This is a prospective cohort study to determine if implementation of electronic devices for teaching promotes myopia development and progression and affects visual function in primary schoolchildren.

The schools will introduce e-books to their students in some classes. Signed informed consent letters from parents will be obtained prior to subject recruitment and data collection. Eye examination and data collection will be conducted in primary school campus. The children from two local primary schools in same grade will be assigned into two groups by their schools. One group will use e-books (e-book group) to study course materials assigned by their teachers whereas another group will use ordinary textbooks (control group). Their refractive errors, axial length (AXL) and binocular functions will be measured and monitored at six-month intervals for a maximum of 2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 10 Years

Eligibility

Inclusion Criteria:

• Chinese

• study local primary schools

Exclusion Criteria:

• with any ocular diseases and binocular anomalies might affect visual functions or refractive development

• with history of eye surgery

• have undertaken any kind of myopia control treatment, such as bifocal lenses, orth-K, eyedrops (e.g. atropine)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Myopia

Locations

Country	Name	City	State
China	School of Optometry	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Tung Wah Group of Hospitals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Phoria at distance and near	Howell phoria cards	every 6-month	No
Primary	Changes in refractive errors	cycloplegic autorefraction	2 years	No
Secondary	changes in axial length	measured by the Zeiss IOLMaster after cycloplegia	2 years	No
Secondary	Keratometric changes		2 years	No