EuPatch (European Paediatric Amblyopia Treatment Study for Children): the role of glasses wearing in amblyopia treatment

The role of glasses wearing in amblyopia treatment: a randomised controlled multicentre trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN51712593

Enrollment

346

Registered

2013-06-26

Start date

2013-06-20

Completion date

Unknown

Last updated

2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amblyopia Eye Diseases Amblyopia

Interventions

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 g

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Austria, England, Germany, Greece, Switzerland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 8, 2026