Managing short sightedness using glasses/contact lenses
Research type
Research Study
Full title
Controlling Myopia Progression through Optical Interventions
IRAS ID
151921
Contact name
Lesley Lockhart
Contact email
Sponsor organisation
VISTAKON®, Division of Johnson & Johnson Vision Care, Inc.
Research summary
Short-sightedness (myopia) is an important public health problem and is the fifth most common cause of vision impairment. Short-sightedness in children typically develops at approximately 6 to 8 years of age, and the progression is typically faster at a younger age. Therefore controlling the short-sightendess progression starting early at its on-set stage is most beneficial.
This study is being done to see if different types of optical treatments can slow down the worsening of short sightedness and to find out how comfortable and acceptable these optical treatments are to the children in the study. The study includes two treatment groups: a soft contact lens group and spectacles group.
One of the two types of study lenses used in the study is an investigational product. It is considered “investigational” because it has not yet completed the requirements to be cleared or approved by any regulatory authorities e.g. the Medicines and Healthcare products Regulatory Agency (“MHRA”) for the UK, etc.The study is expected to include about 350 short sighted children between the ages 7 years and 12 years of age. Approximately 500 participants are expected to be screened for the study with a goal of approximately 350 eligible participants to be randomised and a minimum of 200 participants to complete the study. Approximately 200 children will be assigned to the soft contact lens group and 150 children to the glasses group.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
14/NW/1009
Date of REC Opinion
18 Aug 2014
REC opinion
Further Information Favourable Opinion