AmblyopiaAMBERNCT05114252
Amblyopia and Stereoptic Games for Vision
A study testing Vivid Vision Home and Refractive error correction in people with Amblyopia and Healthy, run by Pawel Matusz, PhD at 1 site in Switzerland.
Trial summary
Amblyopia is the most common developmental vision disorder in children, caused by abnormal visual experience in early life, especially a difference in refraction between the eyes, a misalignment of the eye axes, a combination of both. Read more about this study
- Who is it for?
- Ages 6 to 35 yearsHealthy volunteers can take part
- What is being tested?
- Vivid Vision Home and Refractive error correction
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Dec 2022to 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 6 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged between 6 and 35 years old,
- Residual amblyopia defined as Best-Correct Visual Acuity (BCVA) of ≤ 20/20 in the amblyopic eye, an impairment of ≥ 2 lines in the amblyopic eye persisting even after refraction correction,
- Stable BCVA for at least 2 consecutive measurements over 6 months,
- Signed Informed Consent from the child's legal representative, by both the child and his/her legal representative for participants older than 14 years, or by full-aged participants themselves.
- Aged between 6 and 35 years old,
- Signed Informed Consent from the child's legal representative, by both the child and his/her legal representative for participants older than 14 years, or by full-aged participants themselves.
Who cannot join
- Untreated or newly diagnosed anisometropic, strabismic or combined amblyopia, that is a child with BCVA interocular difference of ≥ 2 lines,
- Current atropine treatment or atropine treatment 3 months prior to enrolment in the study,
- Auditory deficits or loss,
- Eye surgery except those to correct strabismus,
- Strabismus over 20 dioptres (D) or with large eccentric fixation,
- Coexistence of ocular or neurological disease (e.g., seizure or epilepsy, incomitant strabismus, nerve palsy, horror fusionis),
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- Developmental delay or disorder (e.g., dyslexia, dyspraxia, attention deficity hyperactivity disorder, autism spectrum disorders),
- Inability to follow and complete the procedures of the study (e.g., psychological or sensorimotor disorders).
- HEALTHY INDIVIDUALS COHORT
- Auditory deficits or loss,
- Eye surgery except those to correct strabismus,
- Strabismus over 20D or with large eccentric fixation,
- Coexistence of ocular or neurological disease (e.g., seizure or epilepsy, incomitant strabismus, nerve palsy, horror fusionis),
- Developmental delay or disorder (e.g., dyslexia, dyspraxia, ADHD, ASD),
- Inability to follow and complete the procedures of the study (e.g., psychological or sensorimotor disorders).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stereoptic Serious Games as a Visual Rehabilitation Tool for Individuals With Residual Amblyopia: A Crossover Randomized Controlled Trial - AMBlyopia and stEReoptic Games for Vision
Amblyopia is the most common developmental vision disorder in children, caused by abnormal visual experience in early life, especially a difference in refraction between the eyes, a misalignment of the eye axes, a combination of both. Besides a significant reduced visual acuity, the patients show deficits in 3D vision and functional vision impairment like reduced reading speed, selective attention or motor control skills. The gold standard treatment for amblyopia, occlusion therapy, can lead to relapses or residual amblyopia (i.e., amblyopia that persist into adulthood). The current study aims to test the efficacy of a novel home-based child-friendly rehabilitation program for amblyopia, Vivid Vision Home, involving playing serious videogames on a virtual reality (VR) headset at home. The VR training will be compared to standard care (wearing a spectacle correction) and to age-matched typically developing individuals. A cross-over design will be used so that each participant will receive both treatments (games, spectacles). There is a growing number of studies showing benefits of binocular stimulation for visual acuity and stereovision, but provided mainly by level III studies, with a need for rigorous level I or II studies, using more engaging therapies, to confirm or refute the efficacy of this approach as an adjunct or replacement for current amblyopia treatments. Embedding binocular stimulation in engaging, immersive serious games delivered on VR headsets at home, as implemented by Vivid Vision Home, can address this question.
Read the detailed description
Amblyopia is the most common developmental vision disorder in children, affecting 1-5% of the population in developed countries. It mostly results from a difference in refraction between the eyes (anisometropia), a misalignment of the eye axes (strabismus), a combination of both, or visual deprivation (due to congenital cataract, e.g.). Besides a significant reduced visual acuity, the patients show binocular dysfunction leading to functional vision impairment like reduced reading speed, selective attention or motor control skills.
Whilst the disorder is commonly diagnosed around the age of 3-5 years, up to 50% of children will be left with residual amblyopia mainly due to a late diagnosis and start of treatment, poor compliance with treatment, not diagnosed or considered eccentric fixation. The gold standard treatment consists of the occlusion therapy, patching the dominant/healthy eye for 2-6 hours/day every day for several months up to years. However, an eye patch and the demand to use the weaker eye for visual tasks is challenging and so poorly complied with by pediatric patients. These problems in compliance lead to relapses (14-25%) or residual amblyopia (i.e., poor vision that persist into adulthood) creating multiple medical and social problems for the patients (including cognitive and emotional processing), their families and the society.
Serious videogames delivered on tablets have been developed with a more engaging strategy to effectively treat amblyopia. These games focus on binocular stimulation, which targets visual acuity of the amblyopic eye and three-dimensional vision (stereovision), through the presentation of dichoptic images. Such dichoptic image presentation consists of showing a different but complementary image in each eye so that the task can only be performed if information across eyes is combined. Binocular stimulation signifies that both eyes are challenged but the devices are programmed in a way so that the weaker eye is primarily performing a given visual task.
The objective of this project is to improve visual function of the amblyopic eye using image-fusion and stereopsis through playing videogames in a Virtual Reality (VR) environment. Also, besides the improvements of visual acuity and potentially stereovision, such VR-based serious games interventions can positively impact other aspects like cognitive and motor functions. The visual deficits seen in amblyopia are thought to be related to problems in attending to visual task-relevant objects, suggesting that such deficits in selective-attentional skills can hamper vision recovery. Similarly, poor stereovision will be reflected in deficits in motor control skills as seen in individuals with amblyopia. Our VR-based serious games training will have similar ingredients to those that are supposed to improve attentional skills and may have a positive impact on motor control skills. The VR-based technology developed by Vivid Vision to be used in the present study is FDA approved and CE (Conformité Européene) certified. They are offering virtual reality videogames with headsets, which may increase the beneficial treatment effect by a reduction of the misperception of 3-dimensional movement.
The present project aims to test the described benefit in a home-based, child-friendly rehabilitation program involving serious video games in a virtual reality environment in children, adolescents, and young adults with residual amblyopia, compared to standard care (refractive correction) and to age-matched healthy individuals. The study has been designed as a blinded randomized cross-over trial to increase the available evidence allowing for a qualified evaluation of the benefit of binocular stimulation and for demonstrating a beneficial effect also in residual amblyopia in childhood and in older patients.
- Being tested
- Vivid Vision Home, Refractive error correction
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivid Vision HomeDevice
The study intervention consists of playing serious games (Vivid Vision, San Francisco, USA) embedded in a virtual reality headset in a home environment 5 days a week for 30 minutes over 8 weeks (20 h of total gaming).
Refractive error correctionBehavioural
Also called Standard care
The control intervention will be refractive error correction that consists of wearing the lenses with the prescribed correction for 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Participants with amblyopia in the serious games intervention | Experimental | Participants with amblyopia receiving the experimental intervention consisting of serious videogames focusing on binocular function (with image modification) in a virtual reality environment. Receives: Device: Vivid Vision Home |
| Participants with amblyopia in the standard care intervention | Active comparator | Participants with amblyopia receiving the standard care intervention consisting of wearing spectacles with individualized refractive correction. Receives: Behavioral: Refractive error correction |
| Healthy participants | Active comparator | Participants without amblyopia or other conditions receiving the experimental intervention consisting of serious videogames focusing on binocular function (without any image modification) in a virtual reality environment. Receives: Device: Vivid Vision Home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity
Best-corrected visual acuity refers to the measurement of the best vision correction that can be achieved using glasses or contact lenses.
Measured: Baseline for Treatment A
Best Corrected Visual Acuity
Best-corrected visual acuity refers to the measurement of the best vision correction that can be achieved using glasses or contact lenses.
Measured: Post-test for Treatment A (2 months)
Best Corrected Visual Acuity
Best-corrected visual acuity refers to the measurement of the best vision correction that can be achieved using glasses or contact lenses.
Measured: Follow-up for Treatment A (2 months)/Baseline for Treatment B
Best Corrected Visual Acuity
Best-corrected visual acuity refers to the measurement of the best vision correction that can be achieved using glasses or contact lenses.
Measured: Post-test for Treatment B (2 months)
Best Corrected Visual Acuity
Best-corrected visual acuity refers to the measurement of the best vision correction that can be achieved using glasses or contact lenses.
Measured: Follow-up after Treatment B (2months)
Secondary outcomes (26)
Binocular vision measured in arc sec with clinical tests
Stereoacuity refers to the the smallest detectable depth difference that can be seen in binocular vision. When binocular vision is present, the binocular function is the best stereoscopic acuity, measured in arc seconds, achieved for any of the below mentioned tests:
Lang I and Lang II-Stereotest Titmus test Bagolini striated glasses test TNO-Test (TNO: Nederlandse Organisatie voor Toegepast Natuurwetenschappelijk Onderzoek)
Measured: Baseline, every week during experimental treatment, after experimental treatment (2 months) and 2 months follow-up
Binocular vision measured in arc sec with a tablet test
Stereoacuity refers to the the smallest detectable depth difference that can be seen in binocular vision. Stereoacuity, expressed in arc sec, will be investigated with a novel, 3D tablet-based test called ASTEROID.
Measured: Baseline, every week during experimental treatment, after experimental treatment (2 months) and 2 months follow-up
Binocular vision (interocular misalignment) measured with clinical tests
Interocular misalignment refers to the degree to which two eyes's axes are not parallel. It can be measured with the Cover test. Result of Cover test of one eye turning upon covering the other indicates eye misalignment. Red filter involves asking patient to fixate on a white circle at the end of the room and placing a red filter on the patient's fellow eye. If the patient reports a red pinkish light, their eyes are aligned, and they do not have strabismus. The location of the red circle in relation to the white circle will tell the examiner about also the type of the strabismus.
Measured: Baseline, every week during experimental treatment, after experimental treatment (2 months) and 2 months follow-up
Stereoacuity estimated with Vivid Vision Home software
Five built-in tests in the Vivid Vision Home software will be performed to delineate the patient's treatment (in the amblyopia cohort) and to adjust the treatment to the potential improvements, by setting parameters to increase or decrease the amount of blur or occlusion needed for the patient to play the games. In the healthy cohort, the same tests will be done, but they rather aim to accommodate the prisms built in the VR headset to the participants' view.
A Composite Depth Score estimate is measured (1-30) where 0 indicates no stereovision and 30 - 20 arc sec. Patients need to choose which of 4 circular stimuli are floating off the surface, where with each correct response the stimuli become smaller and the disparity decreases.
Measured: Baseline, every week during experimental treatment, after experimental treatment (2 months) and 2 months follow-up
Binocular vision estimated with Vivid Vision Home software
Five built-in tests in the Vivid Vision Home software will be performed to delineate the patient's treatment (in the amblyopia cohort) and to adjust the treatment to the potential improvements, by setting parameters to increase or decrease the amount of blur or occlusion needed for the patient to play the games. In the healthy cohort, the same tests will be done, but they rather aim to accommodate the prisms built in the VR headset to the participants' view.
Degree of binocular vision is estimated with a virtual Worth 4 Dot test, revealing normal vision, double vision, or suppression of left or right eye.
Measured: Baseline, every week during experimental treatment, after experimental treatment (2 months) and 2 months follow-up
Ocular posture adjustment estimated with Vivid Vision Home software
Five built-in tests in the Vivid Vision Home software will be performed to delineate the patient's treatment (in the amblyopia cohort) and to adjust the treatment to the potential improvements, by setting parameters to increase or decrease the amount of blur or occlusion needed for the patient to play the games. In the healthy cohort, the same tests will be done, but they rather aim to accommodate the prisms built in the VR headset to the participants' view.
The minimal correction needed for patient's ocular posture in a horizontal, vertical and rotational prism is estimated in prism diopters through a Maddox rod like test, where patient aligns vertical and horizontal lines with a spot or a pair of horizontal lines
Measured: Baseline, every week during experimental treatment, after experimental treatment (2 months) and 2 months follow-up
Vergence facility estimated with Vivid Vision Home software
Five built-in tests in the Vivid Vision Home software will be performed to delineate the patient's treatment (in the amblyopia cohort) and to adjust the treatment to the potential improvements, by setting parameters to increase or decrease the amount of blur or occlusion needed for the patient to play the games. In the healthy cohort, the same tests will be done, but they rather aim to accommodate the prisms built in the VR headset to the participants' view.
The speed of patient's ability to switch between difference vergence demands is estimated in seconds as the participant is aligning a series of shapes or symbols until they make up a single line.
Measured: Baseline, every week during experimental treatment, after experimental treatment (2 months) and 2 months follow-up
Vergence range estimated with Vivid Vision Home software
Five built-in tests in the Vivid Vision Home software will be performed to delineate the patient's treatment (in the amblyopia cohort) and to adjust the treatment to the potential improvements, by setting parameters to increase or decrease the amount of blur or occlusion needed for the patient to play the games. In the healthy cohort, the same tests will be done, but they rather aim to accommodate the prisms built in the VR headset to the participants' view.
Participant's maximal horizontal and/or vertical vergence ability is estimated in prism diopters as the the participant is aligning a series of shapes or symbols until they make up a single line.
Measured: Baseline, every week during experimental treatment, after experimental treatment (2 months) and 2 months follow-up
Reading skills
For this purpose, we will use the MNRead test. The test is administered through an app on an iPad©, electronically recorded (connected to a computer), and is designed to assess reading skills in people with low vision (MNRead, French electronic version, 2016). The MNRead test measures the smallest print readable by the person without making significant errors, as well as the smallest print that the person can read with maximum speed and the maximum reading speed.
Measured: Baseline, after each treatment (2 months) and 2 months follow-up
Visual selective attention: Behavioral processes
Spatial cuing task designed by Folk et al. (1992), adapted to the current project's aims, will be administered separately for the amblyopic/fellow and the dominant eye. Participants search for a target diamond of a predefined color (e.g. blue) in an array of differently colored bars and need to report the bar's orientation (horizontal or vertical) by pressing keyboard keys. On every trial, this search array is preceded by an array where a task-irrelevant visual distractor is present that can have the same or a different color than the target. On 50% of the trials the cues are accompanied by trials.
Selective attention is measured behaviorally by cuing effects, i.e., the difference in speed of responding when the cue and target are in the same versus different locations.
Strength of visual selective attention is measured by the the difference in cuing effects elicited by distractors that matched the color of the target compared to distractors that matched a different color.
Measured: Baseline, after each treatment (2 months) and 2 months follow-up
Visual selective attention: Traditional EEG/ERP processes
EEG will be recorded while participants are doing the adapted Folk et al.'s spatial cuing task (see Outcome 10).
Traditional EEG processes of visual selective attention is measured by the N2pc event-related potential (ERP)component, a traditional marker of visual selective attention. The N2pc is a negative-going voltage deflection observed app. 200-300ms after presentation of the stimulus of interest, larger over electrodes contralateral than ipsilateral to the side of the stimulus.
Strength of visual selective attention here is measured by the difference in the mean amplitude in the N2pc time-window elicited by distractors that matched the colour of the target compared to distractors that matched a different colour.
Measured: Baseline, after each treatment (2 months) and 2 months follow-up
Visual selective attention: Topographic EEG/ERP processes
EEG will be recorded while participants are doing the adapted Folk et al.'s spatial cuing task (see Outcome 10).
Topographic analyses of the EEG/ERPs focus on the reference-independent, multivariate characteristics of the electrical field across the whole scalp. Here, the topographic analyses involve using clustering of the group-averaged EEG/ERP activity over the time-window of the N2pc (see Outcome 11) to identify periods of stable topographic activity (topographic maps). After identification of an optimal number of the topographic maps, they are fit back into single-subject data; parameters like map duration (map onset, map offset) and global explained variance will be analysed.
Strength of visual selective attention here is measured by the difference in the duration of maps present over the N2pc time-window elicited by distractors that matched the colour of the target compared to distractors that matched a different colour.
Measured: Baseline, after each treatment (2 months) and 2 months follow-up
Visual selective attention: Global Field Power of EEG/ERP processes
EEG will be recorded while participants are doing the adapted Folk et al.'s spatial cuing task (see Outcome 10).
Global Field Power (GFP) of the EEG/ERPs is a standard deviation of the moment-by-moment voltage of the electrical field across the whole scalp. Here, the GFP analyses are conducted over the time-window of the N2pc (see Outcome 11) to identify if EEG responses across different conditions were modulated by differences in strength of the response the same, statistically indistinguishable brain network.
Strength of visual selective attention here is measured by the difference in the GFP present over the N2pc time-window elicited by distractors that matched the colour of the target compared to distractors that matched a different colour.
Measured: Baseline, after each treatment (2 months) and 2 months follow-up
Audiovisual selective attention: Behavioral processes
Audiovisual selective attention will be measured, like the visual attention processes, with the Folk et al.'s spatial cuing task (see Outcome 10).
Selective attention is measured by cuing effects, i.e., the difference in speed of responding when the cue and target are in the same versus different locations.
Strength of audiovisual selective attention here is measured by the the difference in cuing effects elicited by colour distractors accompanied by sounds compared to colour distractors presented without sounds.
Measured: Baseline, after each treatment (2 months) and 2 months follow-up
Audiovisual selective attention: Traditional EEG/ERP processes
EEG will be recorded while participants are doing the adapted Folk et al.'s spatial cuing task (see Outcome 10).
Traditional EEG processes of visual selective attention is measured by the N2pc event-related potential (ERP)component, a traditional marker of visual selective attention. The N2pc is a negative-going voltage deflection observed app. 200-300ms after presentation of the stimulus of interest, larger over electrodes contralateral than ipsilateral to the side of the stimulus. The N2pc has been observed during studies of attention to audiovisual stimuli.
Strength of audiovisual selective attention here is measured by the difference in the mean amplitude in the N2pc time-window elicited by colour distractors accompanied by sounds compared to colour distractors presented without sounds.
Measured: Baseline, after each treatment (2 months) and 2 months follow-up
Audiovisual selective attention: Topographic EEG/ERP processes
EEG will be recorded while participants are doing the adapted Folk et al.'s spatial cuing task (see Outcome 10).
Topographic analyses of the EEG/ERPs focus on the reference-independent, multivariate characteristics of the electrical field across the whole scalp. Here, the topographic analyses involve using clustering of the group-averaged EEG/ERP activity over the time-window of the N2pc (see Outcome 11) to identify periods of stable topographic activity (topographic maps). After identification of an optimal number of the topographic maps, they are fit back into single-subject data; parameters like map duration (map onset, map offset) and global explained variance will be analysed.
Strength of audiovisual selective attention here is measured by the difference in the duration of maps present over the N2pc time-window elicited by colour distractors accompanied by sounds compared to colour distractors presented without sounds.
Measured: Baseline, after each treatment (2 months) and 2 months follow-up
Audiovisual selective attention: Global Field Power of EEG/ERP processes
EEG will be recorded while participants are doing the adapted Folk et al.'s spatial cuing task (see Outcome 10).
Global Field Power (GFP) of the EEG/ERP processes is a standard deviation of the moment-by-moment voltage of the electrical field across the whole scalp. Here, the GFP analyses are conducted over the N2pc time-window (see Outcome 11) to identify if EEG responses across different conditions were modulated by differences in strength of the response the same, statistically indistinguishable brain network.
Strength of audiovisual selective attention here is measured by the difference in the GFP present over the N2pc time-window elicited by colour distractors accompanied by sounds compared to colour distractors presented without sounds.
Measured: Baseline, after each treatment (2 months) and 2 months follow-up
Motor control: movement duration
Motor planning and execution deficits will be evaluated during a visually guided reach-to-grasp task at different reaching depths using reflective markers attached to the upper limb.
To evaluate the movement duration, we will calculate the time passed from the start to the end of the movement. We will split it into: reaching phase, manipulating phase and withdrawal phase.
This will be done for 3 conditions: monocular dominant, monocular non-dominant, and binocular.
Measured: Baseline, after each treatment (2 months) and 2 months follow-up
Motor control: reaction time
Motor planning and execution deficits will be evaluated during a visually guided reach-to-grasp task at different reaching depths using reflective markers attached to the upper limb.
To evaluate the reaction time, we will calculate the time passed from the start of the trial (indicated with a custom script) to the start of the movement.
This will be done for 3 conditions: monocular dominant, monocular non-dominant, and binocular.
Measured: Baseline, after each treatment (2 months) and 2 months follow-up
Motor control: smoothness
Motor planning and execution deficits will be evaluated during a visually guided reach-to-grasp task at different reaching depths using reflective markers attached to the upper limb.
To evaluate the smoothness, we will extract the information from the marker placed on the hand and we will calculate its trajectory straightness. The straighther, the smoother the data is, which indicates better motor control. We will split it into: reaching phase, manipulating phase and withdrawal phase.
This will be done for 3 conditions: monocular dominant, monocular non-dominant, and binocular.
Measured: Baseline, after each treatment (2 months) and 2 months follow-up
Motor control: maximum grip aperture
Motor planning and execution deficits will be evaluated during a visually guided reach-to-grasp task at different reaching depths using reflective markers attached to the upper limb.
To evaluate the maximum grip aperture, we will extract the difference between the positions of the marker on the index and the marker on the thumb. The maximum difference will be used.
This will be done for 3 conditions: monocular dominant, monocular non-dominant, and binocular.
Measured: Baseline, after each treatment (2 months) and 2 months follow-up
Motor control: time to maximum grip aperture
Motor planning and execution deficits will be evaluated during a visually guided reach-to-grasp task at different reaching depths using reflective markers attached to the upper limb.
To evaluate the time to maximum grip aperture, we will extract the difference between the positions of the marker on the index and the marker on the thumb. The time at which the maximum difference occured will be used.
This will be done for 3 conditions: monocular dominant, monocular non-dominant, and binocular.
Measured: Baseline, after each treatment (2 months) and 2 months follow-up
Motor control: cortical responses of motor planning
Motor planning and execution deficits will be evaluated during a visually guided reach-to-grasp task at different reaching depths using reflective markers attached to the upper limb.
We will use a 128-channel EEG system to record brain activity during this task. We will perform frequency analysis to investigate the power at a specific frequency band between the start signal (custom script) till the start of the movement, time in which the participant should have planned the movement.
This will be done for 3 conditions: monocular dominant, monocular non-dominant, and binocular.
Measured: Baseline, after each treatment (2 months) and 2 months follow-up
Motor control: cortical responses of motor execution
Motor planning and execution deficits will be evaluated during a visually guided reach-to-grasp task at different reaching depths using reflective markers attached to the upper limb.
We will use a 128-channel EEG system to record brain activity during this task. We will perform frequency analysis to investigate the power at a specific frequency band after the start of the movement, time in which the participant is executing the movement.
This will be done for 3 conditions: monocular dominant, monocular non-dominant, and binocular.
Measured: Baseline, after each treatment (2 months) and 2 months follow-up
Cortical visual responses
Visually evoked potentials (VEPs) will also be measured as an electrophysiological (EEG) index of the integrity (strength) of the visual cortical pathway from the retina to the occipital cortex. VEPs originate from the occipital cortex that receives and interprets visual signals. They consist of a sequence of voltage peaks measured over the occipital electrodes: negative peak (N1), positive peak (P1), negative peak (N2). VEPs will be recorded, for each eye separately, from the responses to the color targets in the selective-attention tasks.
Measured: Baseline, after each treatment (2 months) and 2 months follow-up
Pediatric Eye Questionnaire (PedEyeQ)
Rasch scores for each questionnaire item will be obtained from published look-up tables available at www.pedig.net, and used to calculate a score for each amblyopic participant (Parent-PedEyeQ for <18-year-olds; adapted Child-PedEyeQ for >18-year-olds) and each treatment arm and group at each visit. Scores will also be converted to a 0-100 scale to aid in interpretation.
Healthy individuals or their parents will not complete this questionnaire.
Child PedEyeQ: Functional Vision, Bothered by Eyes and Vision, Social, Frustration / Worry . Parent PedEyeQ: Impact on Parent and Family, Worry about Child's Eye Condition, Worry about Self-perception and Interactions, Worry about Functional Vision
Measured: Baseline, after each treatment (2 months) and 2 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start6 Dec 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies 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
- Model description
- Monocentric blinded crossover randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pawel Matusz, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva, University of Lausanne Hospitals, Eye Hospital Jules Gonin
- Responsible party
- Sponsor-investigator, Pawel Matusz, PhD, HES-SO Valais-Wallis
- Investigators
- Heimo Steffen, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114252
- Sponsor's protocol ID
- 2021-01172
- Acronym
- AMBER
- Status last verified
- May 2023
- First submitted
- 5 Oct 2021
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data will be shared upon publication of results in a pseudonymized manner, according to local and european regulations of data protection and open science.
Publications
Vedamurthy I, Nahum M, Huang SJ, Zheng F, Bayliss J, Bavelier D, Levi DM. A dichoptic custom-made action video game as a treatment for adult amblyopia. Vision Res. 2015 Sep;114:173-87. doi: 10.1016/j.visres.2015.04.008. Epub 2015 Apr 24.
PubMed 25917239Birch 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 25727578Gambacorta C, Nahum M, Vedamurthy I, Bayliss J, Jordan J, Bavelier D, Levi DM. An action video game for the treatment of amblyopia in children: A feasibility study. Vision Res. 2018 Jul;148:1-14. doi: 10.1016/j.visres.2018.04.005. Epub 2018 May 12.
PubMed 29709618Ziak P, Holm A, Halicka J, Mojzis P, Pinero DP. Amblyopia treatment of adults with dichoptic training using the virtual reality oculus rift head mounted display: preliminary results. BMC Ophthalmol. 2017 Jun 28;17(1):105. doi: 10.1186/s12886-017-0501-8.
PubMed 28659140Verghese P, McKee SP, Levi DM. Attention deficits in Amblyopia. Curr Opin Psychol. 2019 Oct;29:199-204. doi: 10.1016/j.copsyc.2019.03.011. Epub 2019 Mar 22.
PubMed 31030000Grant S, Suttle C, Melmoth DR, Conway ML, Sloper JJ. Age- and stereovision-dependent eye-hand coordination deficits in children with amblyopia and abnormal binocularity. Invest Ophthalmol Vis Sci. 2014 Aug 5;55(9):5687-57015. doi: 10.1167/iovs.14-14745.
PubMed 25097239Simon-Martinez C, Antoniou MP, Bouthour W, Bavelier D, Levi D, Backus BT, Dornbos B, Blaha JJ, Kropp M, Muller H, Murray M, Thumann G, Steffen H, Matusz PJ. Stereoptic serious games as a visual rehabilitation tool for individuals with a residual amblyopia (AMBER trial): a protocol for a crossover randomized controlled trial. BMC Ophthalmol. 2023 May 17;23(1):220. doi: 10.1186/s12886-023-02944-y.
PubMed 37198558
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereoptic Serious Games as a Visual Rehabilitation Tool for Individuals With Residual Amblyopia: A Crossover Randomized Controlled Trial - AMBlyopia and stEReoptic Games for Vision
- ClinicalTrials.gov ID
- NCT05114252
- Acronym / sponsor ID
- AMBER / 2021-01172
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pawel Matusz, PhDUniversity, hospital or other
- Collaborators
- University Hospital, Geneva, University of Lausanne Hospitals, Eye Hospital Jules Gonin
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 Nov 2021 (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 is the most common developmental vision disorder in children, caused by abnormal visual experience in early life, especially a difference in refraction between the eyes, a misalignment of the eye axes, a combination of both. Besides a significant reduced visual acuity, the patients show deficits in 3D vision and functional vision impairment like reduced reading speed, selective attention or motor control skills. The gold standard treatment for amblyopia, occlusion therapy, can lead to relapses or residual amblyopia (i.e., amblyopia that persist into adulthood). The current study aims to test the efficacy of a novel home-based child-friendly rehabilitation program for amblyopia, Vivid Vision Home, involving playing serious videogames on a virtual reality (VR) headset at home. The VR training will be compared to standard care (wearing a spectacle correction) and to age-matched typically developing individuals. A cross-over design will be used so that each participant will receive both treatments (games, spectacles). There is a growing number of studies showing benefits of binocular stimulation for visual acuity and stereovision, but provided mainly by level III studies, with a need for rigorous level I or II studies, using more engaging therapies, to confirm or refute the efficacy of this approach as an adjunct or replacement for current amblyopia treatments. Embedding binocular stimulation in engaging, immersive serious games delivered on VR headsets at home, as implemented by Vivid Vision Home, can address this question.
Detailed description
Amblyopia is the most common developmental vision disorder in children, affecting 1-5% of the population in developed countries. It mostly results from a difference in refraction between the eyes (anisometropia), a misalignment of the eye axes (strabismus), a combination of both, or visual deprivation (due to congenital cataract, e.g.). Besides a significant reduced visual acuity, the patients show binocular dysfunction leading to functional vision impairment like reduced reading speed, selective attention or motor control skills.
Whilst the disorder is commonly diagnosed around the age of 3-5 years, up to 50% of children will be left with residual amblyopia mainly due to a late diagnosis and start of treatment, poor compliance with treatment, not diagnosed or considered eccentric fixation. The gold standard treatment consists of the occlusion therapy, patching the dominant/healthy eye for 2-6 hours/day every day for several months up to years. However, an eye patch and the demand to use the weaker eye for visual tasks is challenging and so poorly complied with by pediatric patients. These problems in compliance lead to relapses (14-25%) or residual amblyopia (i.e., poor vision that persist into adulthood) creating multiple medical and social problems for the patients (including cognitive and emotional processing), their families and the society.
Serious videogames delivered on tablets have been developed with a more engaging strategy to effectively treat amblyopia. These games focus on binocular stimulation, which targets visual acuity of the amblyopic eye and three-dimensional vision (stereovision), through the presentation of dichoptic images. Such dichoptic image presentation consists of showing a different but complementary image in each eye so that the task can only be performed if information across eyes is combined. Binocular stimulation signifies that both eyes are challenged but the devices are programmed in a way so that the weaker eye is primarily performing a given visual task.
The objective of this project is to improve visual function of the amblyopic eye using image-fusion and stereopsis through playing videogames in a Virtual Reality (VR) environment. Also, besides the improvements of visual acuity and potentially stereovision, such VR-based serious games interventions can positively impact other aspects like cognitive and motor functions. The visual deficits seen in amblyopia are thought to be related to problems in attending to visual task-relevant objects, suggesting that such deficits in selective-attentional skills can hamper vision recovery. Similarly, poor stereovision will be reflected in deficits in motor control skills as seen in individuals with amblyopia. Our VR-based serious games training will have similar ingredients to those that are supposed to improve attentional skills and may have a positive impact on motor control skills. The VR-based technology developed by Vivid Vision to be used in the present study is FDA approved and CE (Conformité Européene) certified. They are offering virtual reality videogames with headsets, which may increase the beneficial treatment effect by a reduction of the misperception of 3-dimensional movement.
The present project aims to test the described benefit in a home-based, child-friendly rehabilitation program involving serious video games in a virtual reality environment in children, adolescents, and young adults with residual amblyopia, compared to standard care (refractive correction) and to age-matched healthy individuals. The study has been designed as a blinded randomized cross-over trial to increase the available evidence allowing for a qualified evaluation of the benefit of binocular stimulation and for demonstrating a beneficial effect also in residual amblyopia in childhood and in older patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Monocentric blinded crossover randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Participants with amblyopia in the serious games intervention | Experimental | Device: Vivid Vision HomeParticipants with amblyopia receiving the experimental intervention consisting of serious videogames focusing on binocular function (with image modification) in a virtual reality environment. |
| Participants with amblyopia in the standard care intervention | Active comparator | Behavioral: Refractive error correctionParticipants with amblyopia receiving the standard care intervention consisting of wearing spectacles with individualized refractive correction. |
| Healthy participants | Active comparator | Device: Vivid Vision HomeParticipants without amblyopia or other conditions receiving the experimental intervention consisting of serious videogames focusing on binocular function (without any image modification) in a virtual reality environment. |
Who may qualify
- Ages
- 6 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Aged between 6 and 35 years old,
- Residual amblyopia defined as Best-Correct Visual Acuity (BCVA) of ≤ 20/20 in the amblyopic eye, an impairment of ≥ 2 lines in the amblyopic eye persisting even after refraction correction,
- Stable BCVA for at least 2 consecutive measurements over 6 months,
- Signed Informed Consent from the child's legal representative, by both the child and his/her legal representative for participants older than 14 years, or by full-aged participants themselves.
- Aged between 6 and 35 years old,
Key exclusion criteria (15 listed)
- Untreated or newly diagnosed anisometropic, strabismic or combined amblyopia, that is a child with BCVA interocular difference of ≥ 2 lines,
- Current atropine treatment or atropine treatment 3 months prior to enrolment in the study,
- Auditory deficits or loss,
- Eye surgery except those to correct strabismus,
- Strabismus over 20 dioptres (D) or with large eccentric fixation,
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 |
|---|---|---|
| Vivid Vision HomeThe study intervention consists of playing serious games (Vivid Vision, San Francisco, USA) embedded in a virtual reality headset in a home environment 5 days a week for 30 minutes over 8 weeks (20 h of total gaming). | Device | Healthy participants, Participants with amblyopia in the serious games intervention |
| Refractive error correctionAlso: Standard careThe control intervention will be refractive error correction that consists of wearing the lenses with the prescribed correction for 2 months. | Behavioural | Participants with amblyopia in the standard care intervention |
Primary outcome
Best Corrected Visual Acuity
Time frame: Baseline for Treatment A
Best-corrected visual acuity refers to the measurement of the best vision correction that can be achieved using glasses or contact lenses.
Best Corrected Visual Acuity
Time frame: Post-test for Treatment A (2 months)
Best-corrected visual acuity refers to the measurement of the best vision correction that can be achieved using glasses or contact lenses.
Best Corrected Visual Acuity
Time frame: Follow-up for Treatment A (2 months)/Baseline for Treatment B
Best-corrected visual acuity refers to the measurement of the best vision correction that can be achieved using glasses or contact lenses.
Best Corrected Visual Acuity
Time frame: Post-test for Treatment B (2 months)
Best-corrected visual acuity refers to the measurement of the best vision correction that can be achieved using glasses or contact lenses.
Best Corrected Visual Acuity
Time frame: Follow-up after Treatment B (2months)
Best-corrected visual acuity refers to the measurement of the best vision correction that can be achieved using glasses or contact lenses.
26 secondary outcomes
Binocular vision measured in arc sec with clinical tests
Time frame: Baseline, every week during experimental treatment, after experimental treatment (2 months) and 2 months follow-up
Binocular vision measured in arc sec with a tablet test
Time frame: Baseline, every week during experimental treatment, after experimental treatment (2 months) and 2 months follow-up
Binocular vision (interocular misalignment) measured with clinical tests
Time frame: Baseline, every week during experimental treatment, after experimental treatment (2 months) and 2 months follow-up
Stereoacuity estimated with Vivid Vision Home software
Time frame: Baseline, every week during experimental treatment, after experimental treatment (2 months) and 2 months follow-up
Binocular vision estimated with Vivid Vision Home software
Time frame: Baseline, every week during experimental treatment, after experimental treatment (2 months) and 2 months follow-up
Ocular posture adjustment estimated with Vivid Vision Home software
Time frame: Baseline, every week during experimental treatment, after experimental treatment (2 months) and 2 months follow-up
Vergence facility estimated with Vivid Vision Home software
Time frame: Baseline, every week during experimental treatment, after experimental treatment (2 months) and 2 months follow-up
Vergence range estimated with Vivid Vision Home software
Time frame: Baseline, every week during experimental treatment, after experimental treatment (2 months) and 2 months follow-up
Reading skills
Time frame: Baseline, after each treatment (2 months) and 2 months follow-up
Visual selective attention: Behavioral processes
Time frame: Baseline, after each treatment (2 months) and 2 months follow-up
Visual selective attention: Traditional EEG/ERP processes
Time frame: Baseline, after each treatment (2 months) and 2 months follow-up
Visual selective attention: Topographic EEG/ERP processes
Time frame: Baseline, after each treatment (2 months) and 2 months follow-up
Visual selective attention: Global Field Power of EEG/ERP processes
Time frame: Baseline, after each treatment (2 months) and 2 months follow-up
Audiovisual selective attention: Behavioral processes
Time frame: Baseline, after each treatment (2 months) and 2 months follow-up
Audiovisual selective attention: Traditional EEG/ERP processes
Time frame: Baseline, after each treatment (2 months) and 2 months follow-up
Audiovisual selective attention: Topographic EEG/ERP processes
Time frame: Baseline, after each treatment (2 months) and 2 months follow-up
Audiovisual selective attention: Global Field Power of EEG/ERP processes
Time frame: Baseline, after each treatment (2 months) and 2 months follow-up
Motor control: movement duration
Time frame: Baseline, after each treatment (2 months) and 2 months follow-up
Motor control: reaction time
Time frame: Baseline, after each treatment (2 months) and 2 months follow-up
Motor control: smoothness
Time frame: Baseline, after each treatment (2 months) and 2 months follow-up
Motor control: maximum grip aperture
Time frame: Baseline, after each treatment (2 months) and 2 months follow-up
Motor control: time to maximum grip aperture
Time frame: Baseline, after each treatment (2 months) and 2 months follow-up
Motor control: cortical responses of motor planning
Time frame: Baseline, after each treatment (2 months) and 2 months follow-up
Motor control: cortical responses of motor execution
Time frame: Baseline, after each treatment (2 months) and 2 months follow-up
Cortical visual responses
Time frame: Baseline, after each treatment (2 months) and 2 months follow-up
Pediatric Eye Questionnaire (PedEyeQ)
Time frame: Baseline, after each treatment (2 months) and 2 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Background: PubMed 25917239Vedamurthy I, Nahum M, Huang SJ, Zheng F, Bayliss J, Bavelier D, Levi DM. A dichoptic custom-made action video game as a treatment for adult amblyopia. Vision Res. 2015 Sep;114:173-87. doi: 10.1016/j.visres.2015.04.008. Epub 2015 Apr 24.
- 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 29709618Gambacorta C, Nahum M, Vedamurthy I, Bayliss J, Jordan J, Bavelier D, Levi DM. An action video game for the treatment of amblyopia in children: A feasibility study. Vision Res. 2018 Jul;148:1-14. doi: 10.1016/j.visres.2018.04.005. Epub 2018 May 12.
- Background: PubMed 28659140Ziak P, Holm A, Halicka J, Mojzis P, Pinero DP. Amblyopia treatment of adults with dichoptic training using the virtual reality oculus rift head mounted display: preliminary results. BMC Ophthalmol. 2017 Jun 28;17(1):105. doi: 10.1186/s12886-017-0501-8.
- Background: PubMed 31030000Verghese P, McKee SP, Levi DM. Attention deficits in Amblyopia. Curr Opin Psychol. 2019 Oct;29:199-204. doi: 10.1016/j.copsyc.2019.03.011. Epub 2019 Mar 22.
- Background: PubMed 25097239Grant S, Suttle C, Melmoth DR, Conway ML, Sloper JJ. Age- and stereovision-dependent eye-hand coordination deficits in children with amblyopia and abnormal binocularity. Invest Ophthalmol Vis Sci. 2014 Aug 5;55(9):5687-57015. doi: 10.1167/iovs.14-14745.
- Derived from this study: PubMed 37198558Simon-Martinez C, Antoniou MP, Bouthour W, Bavelier D, Levi D, Backus BT, Dornbos B, Blaha JJ, Kropp M, Muller H, Murray M, Thumann G, Steffen H, Matusz PJ. Stereoptic serious games as a visual rehabilitation tool for individuals with a residual amblyopia (AMBER trial): a protocol for a crossover randomized controlled trial. BMC Ophthalmol. 2023 May 17;23(1):220. doi: 10.1186/s12886-023-02944-y.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared upon publication of results in a pseudonymized manner, according to local and european regulations of data protection and open science.
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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.
Heimo Steffen, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vivid Vision Home and Refractive error correction in people with Amblyopia and Healthy, run by Pawel Matusz, PhD at 1 site in Switzerland.
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 15 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 18 May 2023. 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 Switzerland. 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?
Best Corrected Visual Acuity (time frame: Baseline for Treatment A). The study lists 5 primary outcomes in all. 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 NCT05114252, which also lists 7 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 18 May 2023; AzTrials last refreshed its copy on 28 Oct 2026.