European Paediatric and Amblyopia Treatment study for Children (EuPATCH): the role of feedback on adherence to amblyopia treatment

ISRCTN	ISRCTN85110914
DOI	https://doi.org/10.1186/ISRCTN85110914
Secondary identifying numbers	Version 1

Submission date: 31/07/2013
Registration date: 23/08/2013
Last edited: 11/06/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Irene Gottlob
Scientific

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

Email	ig15@le.ac.uk

Study information

Study design	Unmasked randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The effect of feedback to adherence to glasses and patch wear in amblyopia treatment: a randomised clinical trial
Study acronym	EuPATCH
Study objectives	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(s)	NRES Committee East Midlands - Derby, 15/08/2013, ref: 13/EM/0285
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	15/08/2013
Completion date	31/12/2018

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	2 Years
Upper age limit	8 Years
Sex	Both
Target number of participants	102
Key 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
Key exclusion criteria	Children with other ophthalmic or neurological diseases, bilateral amblyopia or premature children.
Date of first enrolment	01/10/2013
Date of final enrolment	31/12/2017

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Leicester

Leicester
LE2 7LX
United Kingdom

Sponsor information

University of Leicester (UK)
University/education

College of Medicine
Biological Sciences and Psychology
Level 4, MSB
Leicester
LE1 7RH
England
United Kingdom

Email	uolsponsor@le.ac.uk
"ROR"	https://ror.org/04h699437

Funders

Funder type

Charity

National Eye Research Centre (NERC) (UK)
Private sector organisation / Universities (academic only)

Alternative name(s): National Eye Research Centre, SightResearchUK, SRUK, NERC
Location: United Kingdom

Results and Publications

Intention to publish date	01/12/2020
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal.
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

11/06/2020: The intention to publish date has been changed from 01/12/2019 to 01/12/2020.
15/01/2018: The overall trial end date has been updated from 01/04/2018 to 31/12/2018. Added the publication and dissemination sharing plans and the participant level data sharing statement.
02/09/2016: The overall trial dates have been updated from 02/09/2013 - 01/09/2015 to 15/08/2013 - 01/04/2018 and the recruitment dates have been updated from 02/09/2013 - 01/03/2015 to 01/10/2013 - 31/12/2017.