EuPatch (European Paediatric Amblyopia Treatment Study for Children): the role of glasses wearing in amblyopia treatment
| ISRCTN | ISRCTN51712593 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51712593 |
| Secondary identifying numbers | 120878 |
- Submission date
- 06/06/2013
- Registration date
- 26/06/2013
- Last edited
- 07/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
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. 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 February 2021
Who is funding the study?
Action Medical Research (UK)
Who is the main contact?
Prof. Irene Gottlob
ig15@le.ac.uk
Contact information
Scientific
Professor Irene Gottlob (MD, Univ. Doz., FRCOphth)
Professor of Ophthalmology
Ophthalmology Group
University of Leicester
Leicester Royal Infirmary
PO Box 65
Leicester
LE2 7LX
United Kingdom
Study information
| Study design | Unmasked randomized 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 to request a patient information sheet |
| Scientific title | The role of glasses wearing in amblyopia treatment: a randomised controlled multicentre trial |
| Study acronym | EuPatch |
| Study objectives | 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(s) | Derby NRES Committee East Midlands, 28/03/2013, ref: 120878 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 17/06/2013 |
| Completion date | 14/02/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 8 Years |
| Sex | Both |
| Target number of participants | 346 |
| Total final enrolment | 341 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 20/06/2013 |
| Date of final enrolment | 12/03/2020 |
Locations
Countries of recruitment
- Austria
- England
- Germany
- Greece
- Switzerland
- United Kingdom
Study participating centre
LE2 7LX
United Kingdom
Sponsor information
University/education
College of Medicine
Biological Sciences and Psychology
Level 4, MSB
Leicester
LE1 7RH
England
United Kingdom
| Website | http://www.le.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/04h699437 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- actionmedres, action medical research for children, AMR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/08/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Data will be available for sharing upon request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2 | 17/01/2014 | 05/06/2023 | No | No |
| Results article | 04/05/2024 | 07/05/2024 | Yes | No |
Additional files
Editorial Notes
07/05/2024: Publication reference added.
05/06/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 17/06/2013 to 20/06/2013.
2. The recruitment end date was changed from 29/09/2017 to 12/03/2020.
3. The overall end date was changed from 14/08/2018 to 14/02/2021.
4. The intention to publish date was changed from 01/12/2022 to 01/08/2023.
4. The plain English summary was updated to reflect these changes.
5. The total final enrolment was added.
6. Greece and Switzerland were added to the countries of recruitment.
12/09/2022: The following changes have been made:
1. The intention to publish date has been added.
2. The IPD sharing statement has been added.
21/06/2017: The following changes were made to the trial record:
1. The recruitment end date was changed from 17/12/2015 to 29/09/2017.
2. The overall trial end date was changed from 17/06/2016 to 14/08/2018.
