AmblyopiaNCT03767985
Patching or Gaming as Amblyopia Treatment?
A study testing Dichoptic video game therapy and Occlusion therapy in people with Amblyopia, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Amblyopia affects 3% of the children and is caused by strabismus, anisometropia or both. Standard treatment is glasses and patching therapy. From North-America, behavioural training, i.e. Read more about this study
- Who is it for?
- Ages 4 to 55 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Dichoptic video game therapy and Occlusion therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Dec 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Amblyopia; an interocular difference in visual acuity of at least 2 logMAR lines.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam, South Holland, 3015 GD
Aveen Kadhum, Bsc, +31 (0)10 7032103, a.kadhum@erasmusmc.nl
Emily T.C. Tan, Bsc, +31(0)650032078, e.tan@erasmusmc.nl
About this study
Official title: A Randomised Clinical Trial Objectively Comparing the Effect of Patching Therapy With Video Gaming for Amblyopia
Amblyopia affects 3% of the children and is caused by strabismus, anisometropia or both. Standard treatment is glasses and patching therapy. From North-America, behavioural training, i.e. dichoptic training, perceptual learning and video gaming, has become increasingly popular to improve visual acuity not only in children but also in adults. In this study we aim to compare the standard occlusion therapy with dichoptic video gaming.
Read the detailed description
Amblyopia affects 3% of the children and is caused by strabismus, anisometropia or both. The standard treatment is glasses and patching therapy. From North-America, behavioural training, i.e. dichoptic training, perceptual learning and video gaming, has become increasingly popular. The rationale behind these games is by using dichoptic stimulation, with the contrast of the stimuli presented to the good eye reduced to match the appearance of the same stimuli when shown to the amblyopic eye, suppression can be alleviated. The many studies now conducted, demonstrate improvement in visual acuity with the games, the effect however is limited, but the rate of improvement is higher. In these studies, prescribed patching-time was compared to realised game-time. We have demonstrated in multiple studies that electronically measured compliance is low: on average only 50%.
In this study we aim to compare the effect of patching therapy, using the ODM to objectively measure compliance, with the effect of a novel dichoptic action video game in children as well as in adults. In addition, the adult participants will undergo fMRI scans to document any changes in the visual cortex before and after either therapy.
- Conditions
- Amblyopia
- Being tested
- Dichoptic video game therapy, Occlusion therapy
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dichoptic video game therapyOther
Dichoptic video gaming for 1 hour per week, viewed through the Oculus Rift.
Occlusion therapyOther
Occlusion therapy for 2 hours per day, 7 days a week
| Study group | Role | What they receive |
|---|---|---|
| Occlusion therapy | Active comparator | Participants are prescribed 2 hours of occlusion therapy per day, 7 days a week. Receives: Other: Occlusion therapy |
| Dichoptic video game therapy | Experimental | Participants receive dichoptic video game therapy: 1 hour per week at the out-patient clinic under direct supervision. Receives: Other: Dichoptic video game therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity improvement
Visual Acuity improvement (logMAR units/time period) in children with amblyopia treated with patching therapy vs dichoptic video gaming
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start18 Dec 2017
- Primary completion24 Jun 2020
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to either the standard patching therapy or the dichoptic video game therapy.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Lijf & Leven, ODAS Stichting, Uitzicht, University of Applied Sciences Utrecht
- Responsible party
- Principal investigator, Sjoukje Elizabeth Loudon, Erasmus Medical Center
- Investigators
- Johannes R Vingerling, MD, PhD, Study director, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767985
- Sponsor's protocol ID
- MEC-2016-439
- Status last verified
- Aug 2021
- First submitted
- 6 Dec 2018
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kadhum A, Tan ETC, Wenner Y, Joosse MV, Loudon SE. Effectiveness of optical treatment in amblyopia and validation of measuring spectacle compliance with the ODM. Ophthalmic Physiol Opt. 2024 Jul;44(5):945-953. doi: 10.1111/opo.13322. Epub 2024 May 17.
PubMed 38757545Tan ET, Kadhum A, Telleman MA, Treur A, Bruijning J, Loudon SE. How do parents experience patching or dichoptic action video gaming as amblyopia treatment? A qualitative study exploring treatment preferences and information needs to facilitate decision-making. Ophthalmic Physiol Opt. 2023 Jul;43(4):649-659. doi: 10.1111/opo.13132. Epub 2023 Apr 3.
PubMed 37010918
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Clinical Trial Objectively Comparing the Effect of Patching Therapy With Video Gaming for Amblyopia
- ClinicalTrials.gov ID
- NCT03767985
- Acronym / sponsor ID
- MEC-2016-439
- Conditions
- Amblyopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Lijf & Leven, ODAS Stichting, Uitzicht, University of Applied Sciences Utrecht
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 24 Jun 2020 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Amblyopia affects 3% of the children and is caused by strabismus, anisometropia or both. Standard treatment is glasses and patching therapy. From North-America, behavioural training, i.e. dichoptic training, perceptual learning and video gaming, has become increasingly popular to improve visual acuity not only in children but also in adults. In this study we aim to compare the standard occlusion therapy with dichoptic video gaming.
Detailed description
Amblyopia affects 3% of the children and is caused by strabismus, anisometropia or both. The standard treatment is glasses and patching therapy. From North-America, behavioural training, i.e. dichoptic training, perceptual learning and video gaming, has become increasingly popular. The rationale behind these games is by using dichoptic stimulation, with the contrast of the stimuli presented to the good eye reduced to match the appearance of the same stimuli when shown to the amblyopic eye, suppression can be alleviated. The many studies now conducted, demonstrate improvement in visual acuity with the games, the effect however is limited, but the rate of improvement is higher. In these studies, prescribed patching-time was compared to realised game-time. We have demonstrated in multiple studies that electronically measured compliance is low: on average only 50%.
In this study we aim to compare the effect of patching therapy, using the ODM to objectively measure compliance, with the effect of a novel dichoptic action video game in children as well as in adults. In addition, the adult participants will undergo fMRI scans to document any changes in the visual cortex before and after either therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Participants are randomized to either the standard patching therapy or the dichoptic video game therapy.
| Arm | Type | Receives |
|---|---|---|
| Occlusion therapy | Active comparator | Other: Occlusion therapyParticipants are prescribed 2 hours of occlusion therapy per day, 7 days a week. |
| Dichoptic video game therapy | Experimental | Other: Dichoptic video game therapyParticipants receive dichoptic video game therapy: 1 hour per week at the out-patient clinic under direct supervision. |
Who may qualify
- Ages
- 4 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Amblyopia; an interocular difference in visual acuity of at least 2 logMAR lines.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dichoptic video game therapyDichoptic video gaming for 1 hour per week, viewed through the Oculus Rift. | Other | Dichoptic video game therapy |
| Occlusion therapyOcclusion therapy for 2 hours per day, 7 days a week | Other | Occlusion therapy |
Primary outcome
Visual Acuity improvement
Time frame: 24 weeks
Visual Acuity improvement (logMAR units/time period) in children with amblyopia treated with patching therapy vs dichoptic video gaming
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Derived from this study: PubMed 38757545Kadhum A, Tan ETC, Wenner Y, Joosse MV, Loudon SE. Effectiveness of optical treatment in amblyopia and validation of measuring spectacle compliance with the ODM. Ophthalmic Physiol Opt. 2024 Jul;44(5):945-953. doi: 10.1111/opo.13322. Epub 2024 May 17.
- Derived from this study: PubMed 37010918Tan ET, Kadhum A, Telleman MA, Treur A, Bruijning J, Loudon SE. How do parents experience patching or dichoptic action video gaming as amblyopia treatment? A qualitative study exploring treatment preferences and information needs to facilitate decision-making. Ophthalmic Physiol Opt. 2023 Jul;43(4):649-659. doi: 10.1111/opo.13132. Epub 2023 Apr 3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes R Vingerling, MD, PhD study director
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dichoptic video game therapy and Occlusion therapy in people with Amblyopia, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sjoukje E Loudon, MD, PhD (+31(0)624927128, s.loudon@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity improvement (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03767985, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.