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. Poor adherence to patching (wearing an eye patch) and glasses wearing has been identified as a potential contributing factor for this problem. Electronic monitors have been used in various studies. However, at present none of these studies have provided feedback to parents about the results of the measurements. In other diseases feedback about compliance to treatment has been shown to be of benefit. For example, it has been shown that feedback to parents and patients about the frequency of use of steroid inhalers can significantly increase adherence to the daily use of inhaled steroids in children with asthma. The aim of this study will be to investigate whether giving feedback to families about the amount of spectacle and patch wear can improve adherence and in turn the outcome of amblyopia therapy.
Who can participate?
Amblyopic children aged between 2 and 8 years.
What does the study involve?
Children will be randomly allocated to one of two groups: the feedback group and the control group. Both groups will be asked to wear their glasses full time and to patch (10 hours/day, 6 days/week) during a 12-week period. Patients will be examined every 3 weeks. Patients within the feedback group will be given feedback from information provided by the monitors.
What are the possible benefits and risks of participating?
There may be no direct benefit to the patient; however, we anticipate that patients in the study will have shorter waiting times and will be seen more often than the comparative NHS treatment, leading to the possible total treatment time being reduced. The study is likely to have only minimal risk with possible occurrence of side effects similar to the usual clinical treatment, including increase of squint, double vision or reduced vision in the better eye (which is almost always reversible).
Where is the study run from?
University of Leicester (UK).
When is the study starting and how long is it expected to run for?
The study is expected to start in September 2013 and run for about 2 years; recruitment will be during the first 1.5 years of the study.
Who is funding the study?
National Eye Research Centre (NERC), UK
Who is the main contact?
Professor Irene Gottlob
ig15@le.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Irene Gottlob
ORCID ID
Contact details
University of Leicester
School of Medicine
Department of Cardiovascular Sciences
Ophthalmology Group
Robert Kilpatrick Clinical Sciences Building P O Box 65
Leicester Royal Infirmary
Leicester
LE2 7LX
United Kingdom
-
ig15@le.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1
Study information
Scientific title
The effect of feedback to adherence to glasses and patch wear in amblyopia treatment: a randomised clinical trial
Acronym
EuPATCH
Study hypothesis
The adherence to amblyopia treatment in children receiving feedback about the level of adherence to patching after 720 hours of prescribed patching over 12 weeks will be significantly higher than those who do not receive feedback.
Ethics approval
NRES Committee East Midlands - Derby, 15/08/2013, ref: 13/EM/0285
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 below to request a patient information sheet
Condition
Amblyopia
Intervention
There will be two treatment arms:
A. Feedback Group: A period of 12 weeks of full-time glasses wearing and patching (10 hrs/day, 6 days/week) followed by feedback on hours of glasses and patch wear at each examination (n=51).
B. Control Group: A period of 12 weeks of full-time glasses wearing and patching (10 hrs/day, 6 days/week) without feedback on hours of glasses and patch wear at each examination (n=51).
The total time the patients will be in the trial is 12 weeks.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Adherence is determined as the the number of hours patched patching over 12 weeks.
Secondary outcome measures
1. Number of hours of glasses wear over the 12 week period.
2. Visual outcome using the formula described by Stewart et al. (% deficit corrected) over the 12 week period
Overall trial start date
15/08/2013
Overall trial end date
31/12/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. Children (age range is between 2-8 years inclusive) with monocular amblyopia (difference of ≥ 0.3 logMAR visual acuity between eyes) due to anisometropia (≥ 1.5D in at least one eye or 1D difference between the two eyes), strabismus or both
2. Previous patching ≤ 18 months
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
102
Participant exclusion criteria
Children with other ophthalmic or neurological diseases, bilateral amblyopia or premature children.
Recruitment start date
01/10/2013
Recruitment end date
31/12/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Leicester
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
-
uolsponsor@le.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
National Eye Research Centre (NERC) (UK)
Alternative name(s)
NERC
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/12/2019
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary