Plain English Summary
Background and study aims
Amblyopia (also called lazy eye) is the most common disease affecting vision in childhood. Currently 30% of children treated for amblyopia do not reach normal vision after a year or more of treatment. Amblyopia is usually treated with glasses wearing and by patching the better eye (wearing an eye patch). There is controversy whether a long period of glasses wearing before patching, called refractive adaptation, helps in treating children with amblyopia. The aim of this study is to perform a trial to test whether refractive adaptation before patching improves the number of successfully treated children with amblyopia.
Who can participate?
Amblyopic children between 3 and 8 years of age
What does the study involve?
Participants are randomly allocated to one of two groups. One group wears glasses for 18 weeks before patching for amblyopia is started, whereas the other group wears the glasses for 3 weeks before patching.
What are the possible benefits and risks of participating?
The participants receive information material for parents, teachers and children about amblyopia. Decorated patches are given to the children. The waiting time for appointments is likely to be shorter. It could be that the total treatment time is reduced. Possible occurrence of side effects is very similar to the usual clinical treatment and could be rarely increase of squint, double vision or reduced vision in the better eye (which is almost always reversible).
Where is the study run from?
1. University of Leicester (UK)
2. Moorfields Eye Hospital (UK)
3. University of Graz (Austria)
4. University of Heidelberg (Germany)
When is the study starting and how long is it expected to run for?
June 2013 to August 2018
Who is funding the study?
Action Medical Research (UK)
Who is the main contact?
Prof. Irene Gottlob
ig15@le.ac.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
120878
Study information
Scientific title
The role of glasses wearing in amblyopia treatment: a randomised controlled multicentre trial
Acronym
EuPatch
Study hypothesis
The number of children successfully treated after 720 hours of prescribed patching over 12 weeks is significantly higher following an initial period of 18 weeks glasses wearing period than 3 weeks glasses wearing period prior to patching therapy.
Ethics approval
Derby NRES Committee East Midlands, 28/03/2013, ref: 120878
Study design
Unmasked randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Amblyopia
Intervention
There are two study arms:
Refractive Adaptation Group (n=173): A period of 18 weeks glasses wearing (i.e. RA) will be followed by a period of 24 weeks combined patching (10hrs/day, 6 days/week) and glasses wearing.
Early Patching Group (n=173): A period of 3 weeks glasses wearing will be followed by a period of 24 weeks combined patching (10hrs/day, 6 days/week) and glasses wearing.
Participants will have an initial full ophthalmologist examination including cycloplegic refraction and will be examined subsequently at 6 weekly intervals with visual acuity measurements.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Number of children successfully treated after 720 hours of prescribed patching over 12 weeks following an initial period of either 3 weeks or 18 weeks glasses wearing prior to patching therapy
Secondary outcome measures
1. To compare the number of patients successfully resolved in ≤ 1080 hours of prescribed patching over 18 weeks, and in ≤ 1440 hours over 24 weeks. Where possible we will also compare the two groups in terms of final visual outcome, total duration of treatment and total amount of patching required
2. To estimate the levels of compliance to glasses and patch wearing
3. To explore the relationship between duration of glasses wearing and patching and improvement in vision
4. To explore whether anisometropes respond better to RA compared to strabismus/mixed patients.
5. To explore whether electronic monitoring influences compliance and visual outcomes
6. Ascertain opinions from carers and children about the study treatment study through a questionnaire given during and on completion of the study
Overall trial start date
17/06/2013
Overall trial end date
14/08/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. Children (aged 3 to 8 years) with newly detected amblyopia (difference of ≥ 0.3 LogMAR visual acuity between eyes)
2. A clinically significant refractive error (≥ 1.5D in at least 1 eye or 1D difference between the two eyes)
3. Able to perform the visual acuity test
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
346
Participant exclusion criteria
1. Children without amblyopia as defined above or with amblyopia as defined above but with other ophthalmic or neurological diseases, or premature children
2. Bilateral amblyopia (vision of better eye corrected visual acuity > 0.2 LogMAR) is also an exclusion criterion
Recruitment start date
17/06/2013
Recruitment end date
29/09/2017
Locations
Countries of recruitment
Austria, Germany, United Kingdom
Trial participating centre
Leicester Royal Infirmary
Leicester
LE2 7LX
United Kingdom
Sponsor information
Organisation
University of Leicester (UK)
Sponsor details
College of Medicine
Biological Sciences and Psychology
Level 4
MSB
Leicester
LE1 7RH
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Action Medical Research (UK)
Alternative name(s)
AMR
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary