Amblyopia, AnisometropicVATNCT05620173
Validation of New Virtual Reality Treatment for Children With Lazy Eye Using the Vedea Amblyopia Therapy (VAT)
A study testing Vedea Amblyopia Therapy (VAT) and Occlusion therapy in people with Amblyopia, Anisometropic and Amblyopia Strabismic, run by Vedea Healthware BV at 2 sites in Netherlands.
Trial summary
The purpose of this clinical study is to validate the effectiveness of the Vedea Amblyopia Therapy (VAT) as a treatment for children with lazy eye. The main question it aims to answer is to prove that the VAT is as effective or more effective than the current gold standard for treating children with lazy eye. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Amblyopia, Anisometropic, Amblyopia Strabismic, Amblyopia
- What is being tested?
- Vedea Amblyopia Therapy (VAT) and Occlusion therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesNetherlands
- Study dates
- 22 Feb 2023to 1 Dec 2024
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- wearing the full corrected refraction for ≥14 weeks to adapt to the glasses
- diagnosed with an unilateral anisometropic, strabismic and/or deprivation amblyopia.
- Amblyopia was defined as an intraocular difference (IOD) in visual acuity (VA) of 0.2 log MAR (2 lines) or more. Angle of strabismus ≤ 10 prism diopters at near and distance fixation. Current clear media (in case of deprivation amblyopia after successful surgery).
- currently under treatment or starting treatment for unilateral amblyopia
- participants must have easy access to an Android device equal to or higher than a Samsung Galaxy S8
- written informed consent by parents or legal guardians
Who cannot join
- current treatment with atropine penalisation
- documented history of severe negative side effects that occur with exposure to VR usage (eg. seizures or epileptic spasms)
- photosensitivity
- no developmental delay
- coexisting ocular pathology or systemic diseases
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, 5223 GZ
The Rotterdam Eye Hospital
Rotterdam, South Holland, 3011 BH
About this study
Official title: 'Validation and Development of New Dichoptic VR-gaming Method to Treat Childhood Amblyopia; Vedea Amblyopia Therapy (VAT)
The purpose of this clinical study is to validate the effectiveness of the Vedea Amblyopia Therapy (VAT) as a treatment for children with lazy eye.
The main question it aims to answer is to prove that the VAT is as effective or more effective than the current gold standard for treating children with lazy eye. This is occlusion therapy by patching the dominant eye.
Participants will play VR-games specifically designed for children with lazy eye for 30 minutes per day, 5 days per week for 16 weeks. This group of children will be compared to children that undergo regular occlusion therapy to see how both treatments options compare.
- Conditions
- Amblyopia, Anisometropic, Amblyopia Strabismic, Amblyopia
- Being tested
- Vedea Amblyopia Therapy (VAT), Occlusion therapy
- Keywords
- RCT, children, Virtual Reality
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vedea Amblyopia Therapy (VAT)Device
Children will use the VAT for 5 days per week, 30 minutes per day. They play VR-games using a VR-headset, which content is optimized for dichoptic training.
Occlusion therapyDevice
Also called Patching
Children are given an eye patch to occlude their dominant eye with for a prescribed number of hours per day. This may typically range anywhere between 2-8 hours per day, depending on the severity of the amblyopia.
| Study group | Role | What they receive |
|---|---|---|
| Vedea Amblyopia Therapy (VAT) then Vedea Amblyopia Therapy | Experimental | Children in this intervention arm will use the VAT for 16 weeks.
After the initial 16 weeks of treatment these children will be allowed to use the VAT for another 16 weeks. Receives: Device: Vedea Amblyopia Therapy (VAT) |
| Occlusion therapy then Vedea Amblyopia Therapy (VAT) | Active comparator | Children in this intervention arm will adhere to a 'care as usual' regimen consisting of occlusion therapy as prescribed by their health care provider. They will do so for 16 weeks.
After the initial 16 weeks of treatment these children will crossover into the experimental arm to examine if they are still responsive to the VAT after already completing 16 weeks of traditional treatment. Receives: Device: Vedea Amblyopia Therapy (VAT); Device: Occlusion therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Visual Acuity measured in LogMAR lines
The LogMAR method is a validated and often used method of measuring visual acuity in children (with or without amblyopia). Possible scores range from 0 (perfect vision) to 1.0 or higher as really bad vision.
Measured: Each clinical visit (approximately 1 month)
Secondary outcomes (2)
Treatment adherence to the VAT defined as time played per day
Adherence will be calculated using the following framework:
- 30 minutes per day = excellent treatment adherence
- 20-29 minutes per day = good treatment adherence
- 15-19 minutes per day = average treatment adherence ≤ 14 minutes per day = bad treatment adherence
Measured: Daily registration of time played up to week 16
Rate of change in visual acuity outcomes
Rate of change is defined as the number of weeks it takes to reach the highest visual acuity score.
Measured: Each clinical visit (approximately 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start22 Feb 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Amblyopia, AnisometropicStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vedea Healthware BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Health Holland, Oogziekenhuis Rotterdam, Rotterdams Oogheelkundig Instituut, Elisabeth-TweeSteden Ziekenhuis, Jeroen Bosch Ziekenhuis
- Responsible party
- Sponsor
- Investigators
- Martha Tjon-Fo-Sang, PhD, Principal investigator, The Rotterdam Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620173
- Sponsor's protocol ID
- NL79107.000.22
- Acronym
- VAT
- Status last verified
- Jul 2024
- First submitted
- 26 Oct 2022
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akizuki H, Uno A, Arai K, Morioka S, Ohyama S, Nishiike S, Tamura K, Takeda N. Effects of immersion in virtual reality on postural control. Neurosci Lett. 2005 Apr 29;379(1):23-6. doi: 10.1016/j.neulet.2004.12.041. Epub 2005 Jan 8.
PubMed 15814192Bailey IL, Lovie-Kitchin JE. Visual acuity testing. From the laboratory to the clinic. Vision Res. 2013 Sep 20;90:2-9. doi: 10.1016/j.visres.2013.05.004. Epub 2013 May 17.
PubMed 23685164Banks MS, Hoffman DM, Kim J, Wetzstein G. 3D Displays. Annu Rev Vis Sci. 2016 Oct 14;2:397-435. doi: 10.1146/annurev-vision-082114-035800. Epub 2016 Aug 15.
PubMed 28532351Birch EE, Li SL, Jost RM, Morale SE, De La Cruz A, Stager D Jr, Dao L, Stager DR Sr. Binocular iPad treatment for amblyopia in preschool children. J AAPOS. 2015 Feb;19(1):6-11. doi: 10.1016/j.jaapos.2014.09.009.
PubMed 25727578Black JM, Hess RF, Cooperstock JR, To L, Thompson B. The measurement and treatment of suppression in amblyopia. J Vis Exp. 2012 Dec 14;(70):e3927. doi: 10.3791/3927.
PubMed 23271400Coco-Martin MB, Pinero DP, Leal-Vega L, Hernandez-Rodriguez CJ, Adiego J, Molina-Martin A, de Fez D, Arenillas JF. The Potential of Virtual Reality for Inducing Neuroplasticity in Children with Amblyopia. J Ophthalmol. 2020 Jun 29;2020:7067846. doi: 10.1155/2020/7067846. eCollection 2020.
PubMed 32676202Feng J, Spence I, Pratt J. Playing an action video game reduces gender differences in spatial cognition. Psychol Sci. 2007 Oct;18(10):850-5. doi: 10.1111/j.1467-9280.2007.01990.x.
PubMed 17894600Foss AJ. Use of video games for the treatment of amblyopia. Curr Opin Ophthalmol. 2017 May;28(3):276-281. doi: 10.1097/ICU.0000000000000358.
PubMed 28141763Gao TY, Guo CX, Babu RJ, Black JM, Bobier WR, Chakraborty A, Dai S, Hess RF, Jenkins M, Jiang Y, Kearns LS, Kowal L, Lam CSY, Pang PCK, Parag V, Pieri R, Raveendren RN, South J, Staffieri SE, Wadham A, Walker N, Thompson B; BRAVO Study Team. Effectiveness of a Binocular Video Game vs Placebo Video Game for Improving Visual Functions in Older Children, Teenagers, and Adults With Amblyopia: A Randomized Clinical Trial. JAMA Ophthalmol. 2018 Feb 1;136(2):172-181. doi: 10.1001/jamaophthalmol.2017.6090.
PubMed 29302694Green CS, Bavelier D. Effect of action video games on the spatial distribution of visuospatial attention. J Exp Psychol Hum Percept Perform. 2006 Dec;32(6):1465-78. doi: 10.1037/0096-1523.32.6.1465.
PubMed 17154785Herbison N, Cobb S, Gregson R, Ash I, Eastgate R, Purdy J, Hepburn T, MacKeith D, Foss A; I-BiT study group. Interactive binocular treatment (I-BiT) for amblyopia: results of a pilot study of 3D shutter glasses system. Eye (Lond). 2013 Sep;27(9):1077-83. doi: 10.1038/eye.2013.113. Epub 2013 Jun 28.
PubMed 23807383Hess RF, Babu RJ, Clavagnier S, Black J, Bobier W, Thompson B. The iPod binocular home-based treatment for amblyopia in adults: efficacy and compliance. Clin Exp Optom. 2014 Sep;97(5):389-98. doi: 10.1111/cxo.12192. Epub 2014 Aug 18.
PubMed 25131694Holmes JM, Manh VM, Lazar EL, Beck RW, Birch EE, Kraker RT, Crouch ER, Erzurum SA, Khuddus N, Summers AI, Wallace DK; Pediatric Eye Disease Investigator Group. Effect of a Binocular iPad Game vs Part-time Patching in Children Aged 5 to 12 Years With Amblyopia: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Dec 1;134(12):1391-1400. doi: 10.1001/jamaophthalmol.2016.4262.
PubMed 27812703Kelly KR, Jost RM, Dao L, Beauchamp CL, Leffler JN, Birch EE. Binocular iPad Game vs Patching for Treatment of Amblyopia in Children: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Dec 1;134(12):1402-1408. doi: 10.1001/jamaophthalmol.2016.4224.
PubMed 27832248Levi DM. Rethinking amblyopia 2020. Vision Res. 2020 Nov;176:118-129. doi: 10.1016/j.visres.2020.07.014. Epub 2020 Aug 28.
PubMed 32866759
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Validation and Development of New Dichoptic VR-gaming Method to Treat Childhood Amblyopia; Vedea Amblyopia Therapy (VAT)
- ClinicalTrials.gov ID
- NCT05620173
- Acronym / sponsor ID
- VAT / NL79107.000.22
- Conditions
- Amblyopia, Anisometropic, Amblyopia Strabismic, Amblyopia
- Keywords
- RCT, children, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Vedea Healthware BVIndustry (pharma, biotech, devices)
- Collaborators
- Health Holland, Oogziekenhuis Rotterdam, Rotterdams Oogheelkundig Instituut, Elisabeth-TweeSteden Ziekenhuis, Jeroen Bosch Ziekenhuis
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 17 Nov 2022 (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.
The purpose of this clinical study is to validate the effectiveness of the Vedea Amblyopia Therapy (VAT) as a treatment for children with lazy eye.
The main question it aims to answer is to prove that the VAT is as effective or more effective than the current gold standard for treating children with lazy eye. This is occlusion therapy by patching the dominant eye.
Participants will play VR-games specifically designed for children with lazy eye for 30 minutes per day, 5 days per week for 16 weeks. This group of children will be compared to children that undergo regular occlusion therapy to see how both treatments options compare.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vedea Amblyopia Therapy (VAT) then Vedea Amblyopia Therapy | Experimental | Device: Vedea Amblyopia Therapy (VAT)Children in this intervention arm will use the VAT for 16 weeks. After the initial 16 weeks of treatment these children will be allowed to use the VAT for another 16 weeks. |
| Occlusion therapy then Vedea Amblyopia Therapy (VAT) | Active comparator | Device: Vedea Amblyopia Therapy (VAT), Device: Occlusion therapyChildren in this intervention arm will adhere to a 'care as usual' regimen consisting of occlusion therapy as prescribed by their health care provider. They will do so for 16 weeks. After the initial 16 weeks of treatment these children will crossover into the experimental arm to examine if they are still responsive to the VAT after already completing 16 weeks of traditional treatment. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- wearing the full corrected refraction for ≥14 weeks to adapt to the glasses
- diagnosed with an unilateral anisometropic, strabismic and/or deprivation amblyopia.
- Amblyopia was defined as an intraocular difference (IOD) in visual acuity (VA) of 0.2 log MAR (2 lines) or more. Angle of strabismus ≤ 10 prism diopters at near and distance fixation. Current clear media (in case of deprivation amblyopia after successful surgery).
- currently under treatment or starting treatment for unilateral amblyopia
- participants must have easy access to an Android device equal to or higher than a Samsung Galaxy S8
Key exclusion criteria (5 listed)
- current treatment with atropine penalisation
- documented history of severe negative side effects that occur with exposure to VR usage (eg. seizures or epileptic spasms)
- photosensitivity
- no developmental delay
- coexisting ocular pathology or systemic diseases
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 |
|---|---|---|
| Vedea Amblyopia Therapy (VAT)Children will use the VAT for 5 days per week, 30 minutes per day. They play VR-games using a VR-headset, which content is optimized for dichoptic training. | Device | Occlusion therapy then Vedea Amblyopia Therapy (VAT), Vedea Amblyopia Therapy (VAT) then Vedea Amblyopia Therapy |
| Occlusion therapyAlso: PatchingChildren are given an eye patch to occlude their dominant eye with for a prescribed number of hours per day. This may typically range anywhere between 2-8 hours per day, depending on the severity of the amblyopia. | Device | Occlusion therapy then Vedea Amblyopia Therapy (VAT) |
Primary outcome
Change from baseline in Visual Acuity measured in LogMAR lines
Time frame: Each clinical visit (approximately 1 month)
The LogMAR method is a validated and often used method of measuring visual acuity in children (with or without amblyopia). Possible scores range from 0 (perfect vision) to 1.0 or higher as really bad vision.
2 secondary outcomes
Treatment adherence to the VAT defined as time played per day
Time frame: Daily registration of time played up to week 16
Rate of change in visual acuity outcomes
Time frame: Each clinical visit (approximately 1 month)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Background: PubMed 15814192Akizuki H, Uno A, Arai K, Morioka S, Ohyama S, Nishiike S, Tamura K, Takeda N. Effects of immersion in virtual reality on postural control. Neurosci Lett. 2005 Apr 29;379(1):23-6. doi: 10.1016/j.neulet.2004.12.041. Epub 2005 Jan 8.
- Background: PubMed 23685164Bailey IL, Lovie-Kitchin JE. Visual acuity testing. From the laboratory to the clinic. Vision Res. 2013 Sep 20;90:2-9. doi: 10.1016/j.visres.2013.05.004. Epub 2013 May 17.
- Background: PubMed 28532351Banks MS, Hoffman DM, Kim J, Wetzstein G. 3D Displays. Annu Rev Vis Sci. 2016 Oct 14;2:397-435. doi: 10.1146/annurev-vision-082114-035800. Epub 2016 Aug 15.
- Background: PubMed 25727578Birch EE, Li SL, Jost RM, Morale SE, De La Cruz A, Stager D Jr, Dao L, Stager DR Sr. Binocular iPad treatment for amblyopia in preschool children. J AAPOS. 2015 Feb;19(1):6-11. doi: 10.1016/j.jaapos.2014.09.009.
- Background: PubMed 23271400Black JM, Hess RF, Cooperstock JR, To L, Thompson B. The measurement and treatment of suppression in amblyopia. J Vis Exp. 2012 Dec 14;(70):e3927. doi: 10.3791/3927.
- Background: PubMed 32676202Coco-Martin MB, Pinero DP, Leal-Vega L, Hernandez-Rodriguez CJ, Adiego J, Molina-Martin A, de Fez D, Arenillas JF. The Potential of Virtual Reality for Inducing Neuroplasticity in Children with Amblyopia. J Ophthalmol. 2020 Jun 29;2020:7067846. doi: 10.1155/2020/7067846. eCollection 2020.
- Background: PubMed 17894600Feng J, Spence I, Pratt J. Playing an action video game reduces gender differences in spatial cognition. Psychol Sci. 2007 Oct;18(10):850-5. doi: 10.1111/j.1467-9280.2007.01990.x.
- Background: PubMed 28141763Foss AJ. Use of video games for the treatment of amblyopia. Curr Opin Ophthalmol. 2017 May;28(3):276-281. doi: 10.1097/ICU.0000000000000358.
- Background: PubMed 29302694Gao TY, Guo CX, Babu RJ, Black JM, Bobier WR, Chakraborty A, Dai S, Hess RF, Jenkins M, Jiang Y, Kearns LS, Kowal L, Lam CSY, Pang PCK, Parag V, Pieri R, Raveendren RN, South J, Staffieri SE, Wadham A, Walker N, Thompson B; BRAVO Study Team. Effectiveness of a Binocular Video Game vs Placebo Video Game for Improving Visual Functions in Older Children, Teenagers, and Adults With Amblyopia: A Randomized Clinical Trial. JAMA Ophthalmol. 2018 Feb 1;136(2):172-181. doi: 10.1001/jamaophthalmol.2017.6090.
- Background: PubMed 17154785Green CS, Bavelier D. Effect of action video games on the spatial distribution of visuospatial attention. J Exp Psychol Hum Percept Perform. 2006 Dec;32(6):1465-78. doi: 10.1037/0096-1523.32.6.1465.
- Background: PubMed 23807383Herbison N, Cobb S, Gregson R, Ash I, Eastgate R, Purdy J, Hepburn T, MacKeith D, Foss A; I-BiT study group. Interactive binocular treatment (I-BiT) for amblyopia: results of a pilot study of 3D shutter glasses system. Eye (Lond). 2013 Sep;27(9):1077-83. doi: 10.1038/eye.2013.113. Epub 2013 Jun 28.
- Background: PubMed 25131694Hess RF, Babu RJ, Clavagnier S, Black J, Bobier W, Thompson B. The iPod binocular home-based treatment for amblyopia in adults: efficacy and compliance. Clin Exp Optom. 2014 Sep;97(5):389-98. doi: 10.1111/cxo.12192. Epub 2014 Aug 18.
- Individual participant dataSharing planned: No
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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.
Martha Tjon-Fo-Sang, PhD principal investigator
The Rotterdam Eye Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vedea Amblyopia Therapy (VAT) and Occlusion therapy in people with Amblyopia, Anisometropic and Amblyopia Strabismic, run by Vedea Healthware BV at 2 sites 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 6 inclusion and 5 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 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Visual Acuity measured in LogMAR lines (time frame: Each clinical visit (approximately 1 month)). 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 NCT05620173, which also lists 25 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 15 Jul 2024.