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A randomised clinical trial objectively comparing the effect of patching therapy with video gaming for amblyopia

A randomised clinical trial objectively comparing the effect of patching therapy with video gaming for amblyopia - Patching or gaming for amblyopiatreatment?

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45946
Enrollment
124
Registered
2017-04-12
Start date
2017-12-18
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

Amblyopia lazy-eye

Interventions

1) Patching therapy The non-amblyopic eye will be patched two hours per day. Compliance with therapy will be monitored with the ODM. 2) Video game A dichoptic custom-made Unreal Tournament video gam

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
The visual acuity after 24 weeks of patching therapy (actual dose received) compared to the gaming therapy in adults and children.

Secondary

MeasureTime frame
- The stereoacuity and contrast sensitivity after 24 weeks of patching therapy (actual dose received) compared to the gaming therapy in adults and children. - The fMRI changes in the visual cortex after either treatment in the adult group. - The quality of life in amblyopia treatment with patching therapy compared to gaming therapy. - Investigating information needs for patients to support patient participation in clinical decision making.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)