Clinical trial NCT02150421: Impact of Electronic Devices on Myopia Development and Progression
Official title: Impact of School Curriculum Engaging Electronic Devices on Myopia Development and Progression in Primary Schoolchildren
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Tung Wah Group of Hospitals
First posted: 2014-05-29
Enrollment: 201
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary schoolchildren in Hong Kong

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Changes in refractive errors
timeFrame: 2 years
Secondary outcomes:
measure: changes in axial length
timeFrame: 2 years
measure: Keratometric changes
timeFrame: 2 years
Other outcomes:
measure: Phoria at distance and near
timeFrame: every 6-month
Locations:
city: Hong Kong
country: China
facility: School of Optometry
Study officials:
affiliation: School of Optometry, The Hong Kong Polytechnic University
name: Carly SY Lam, Professor
role: PRINCIPAL_INVESTIGATOR
References: