Non-Dispensing Myopia Control Family of Prototypes Studies
Research type
Research Study
Full title
Myopia Control Contact Lenses Non-Dispensing Phase Generic Application for a Family of Prototypes
IRAS ID
303213
Contact name
Michel Guillon
Contact email
Sponsor organisation
CooperVision International Limited
Duration of Study in the UK
1 years, 1 months, 31 days
Research summary
Please consider the following to replace the
response given to section A6-1.
Myopia (short sightedness) is increasing in the
UK at a very rapid rate amongst children as
young as 6 years, the condition already
affecting close to one in two European adults
aged 25 to 29 years. The key health concern is
not only that vision correction will be needed
throughout life, but the fact that the higher the
myopia the higher is the prevalence of eye
diseases later in life.
Because of the relationship between level of
myopia and eye disease it is crucial to minimise
myopia progression.
Various approaches are currently used, most
commonly special design contact lenses,
however, all the approaches are only partially
successful, hence, the need to rapidly develop
more efficient solutions.
Myopia control is based upon optimally
correcting distance central vision and adding
other corrections to create a blur in the
peripheral vision. However, the greater the blur
in the peripheral vision is, the more efficient is
myopia control. However, greater blur may
decrease visual acceptance; this cannot be
predicted and requires rapid clinical testing of
series of prototypes to assess their potential.
The Medicines and Healthcare products
Regulatory Agency (MHRA), part of the
Department of Health, indicates that rapid
testing of medical device prototypes can take
place (MHRA Clinical investigations of medical
devices – guidance for manufacturers Section
13) based upon a single application for an
identical testing protocol for a range of
prototypes tested in sequential studies.
The objective of the current application, in
which children and adolescent will wear
prototypes over short periods of time in the
clinic, has for purpose evaluating the precision
of vision (visual acuity) and the vision quality
(visual acceptance). The outcome of each study
being whether or not the prototypes can be
dispensed in follow-up studies.
The studies will be carried out at a single
specialist site each involving approximately 20
participants attending the clinic on two
occasions. The first visit will be the
screening/enrolment visit and the second will be
the test visit.REC name
South East Scotland REC 01
REC reference
21/SS/0078
Date of REC Opinion
10 Jan 2022
REC opinion
Further Information Favourable Opinion