A randomised clinical trial objectively comparing the effect of patching therapy with video gaming for amblyopia
- Conditions
- Amblyopialazy-eye10047518
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 124
Children: Newly diagnosed amblyopia; i.e. never had treatment for amblyopia before with an interocular difference in visual acuity of at least 0.2 logMAR.;Adults: The adult population will be recruited from a previous prospective randomised controlled trial conducted in the Hague in 2001 (MEC-2015-482). In case the amblyopia still persists; i.e. visual acuity difference 0.2 LogMAR lines
Children: Previous amblyopia treatment, a non-comitant or large angle constant strabismus >30Prism dioptres, a neurological disorder, nystagmus, other eye disorders and diminished acuity due to medication, brain damage or trauma.;Adults: a non-comitant or large angle constant strabismus >30Prism Dioptres, a neurological disorder, nystagmus, other eye disorders and diminished acuity due to medication, brain damage or trauma, participants with medical devices or implants that are not certified as MRI-compatible.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The visual acuity after 24 weeks of patching therapy (actual dose received)<br /><br>compared to the gaming therapy in adults and children.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- The stereoacuity and contrast sensitivity after 24 weeks of patching therapy<br /><br>(actual dose received) compared to the gaming therapy in adults and children.<br /><br>- The fMRI changes in the visual cortex after either treatment in the adult<br /><br>group.<br /><br>- The quality of life in amblyopia treatment with patching therapy compared to<br /><br>gaming therapy.<br /><br>- Investigating information needs for patients to support patient participation<br /><br>in clinical decision making. </p><br>