NCT02150421

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

June 22, 2016

Status Verified

June 1, 2016

Enrollment Period

2.2 years

First QC Date

May 26, 2014

Last Update Submit

June 21, 2016

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • Changes in refractive errors

    cycloplegic autorefraction

    2 years

Secondary Outcomes (2)

  • changes in axial length

    2 years

  • Keratometric changes

    2 years

Other Outcomes (1)

  • Phoria at distance and near

    every 6-month

Study Arms (1)

e-book

study the course materials by using e-book

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Primary schoolchildren in Hong Kong

You may qualify if:

  • Chinese
  • study local primary schools

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Optometry

Hong Kong, China

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Carly SY Lam, Professor

    School of Optometry, The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 26, 2014

First Posted

May 29, 2014

Study Start

September 1, 2013

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

June 22, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)