Anisometropic AmblyopiaVISTA3DNCT07563946
3D Movie Viewing vs Occlusion for Treating Amblyopia in Children
A study testing 3D Movie Viewing and Occlusion Therapy in people with Anisometropic Amblyopia and Strabismic Amblyopia, run by Universitat Politècnica de Catalunya.
Trial summary
Amblyopia is a common childhood visual disorder that affects vision in one eye and can also impair depth perception (stereopsis). Standard treatment typically involves occlusion therapy (patching the stronger eye), which improves visual acuity but often does not fully restore binocular vision. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Anisometropic Amblyopia, Strabismic Amblyopia
- What is being tested?
- 3D Movie Viewing and Occlusion Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 4 to 14 years Diagnosis of unilateral amblyopia (anisometropic, strabismic, or mixed) Interocular visual acuity difference ≥ 0.2 logMAR (equivalent to ≥ 2 Snellen lines) Ability to understand and follow age-appropriate instructions Written informed consent from parents or legal guardians Child assent obtained when applicable
Who cannot join
- Previous treatment for amblyopia Ocular surgery within the last 6 months Strabismus with deviation greater than 10 prism diopters Presence of other ocular pathologies affecting vision (e.g., cataract, nystagmus, ptosis, corneal opacity, retinal disease, optic neuropathy) Neurological or cognitive impairment preventing compliance with study procedures Prior intensive exposure to 3D movies or virtual reality/3D video games that could act as a confounding factor Refusal of the child or family to participate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of 3D Movie Viewing Versus Occlusion on Stereopsis and Visual Function in Children With Amblyopia: A Randomized Controlled Trial
Amblyopia is a common childhood visual disorder that affects vision in one eye and can also impair depth perception (stereopsis). Standard treatment typically involves occlusion therapy (patching the stronger eye), which improves visual acuity but often does not fully restore binocular vision.
This study aims to evaluate whether watching 3D movies, combined with occlusion therapy, improves visual outcomes more than occlusion therapy alone in children with amblyopia. The immersive nature of 3D content may stimulate binocular vision and enhance treatment effectiveness.
Read more
In this randomized controlled trial, children aged 4 to 14 years with amblyopia will be assigned to one of two groups: one group will receive standard occlusion therapy, while the other will receive occlusion combined with weekly 3D movie sessions. After an initial phase, all participants will have access to 3D viewing sessions.
The study will assess improvements in depth perception, visual acuity, and eye alignment over time. The goal is to determine whether this combined approach provides additional benefits and could be used as a complementary therapy for amblyopia.
Read the detailed description
Amblyopia is the leading cause of monocular visual impairment in children, with a prevalence of approximately 2-3%. It is commonly associated with strabismus and/or anisometropia and is characterized by reduced visual acuity and deficits in binocular vision, particularly stereopsis. While conventional treatments such as refractive correction and occlusion therapy are effective in improving visual acuity, many patients retain residual deficits in stereopsis and binocular function.
Recent advances in amblyopia treatment have focused on binocular approaches, including perceptual learning, dichoptic training, and virtual reality-based interventions. These methods aim to stimulate binocular interaction and reduce suppression of the amblyopic eye. Among these approaches, 3D movie viewing represents a naturalistic and engaging stimulus that introduces large binocular disparities and may promote binocular integration in a child-friendly environment.
Preliminary evidence from a pilot study conducted by our group demonstrated that a single 3D movie session can produce significant and sustained improvements in stereopsis and visual acuity in children with a history of amblyopia. However, this study lacked a control group and involved only a single exposure session.
The present study is a prospective, randomized, controlled, single-center clinical trial designed to evaluate the efficacy of repeated 3D movie viewing sessions combined with occlusion therapy compared to occlusion therapy alone. Participants will be randomly assigned to either an experimental group (3D viewing plus occlusion) or a control group (occlusion alone). The intervention will consist of 3 to 6 weekly sessions of 3D movie viewing, each lasting approximately 90-120 minutes.
The study includes two phases: an initial comparative phase in which outcomes between groups are assessed after three sessions, and a second phase in which all participants are exposed to additional 3D sessions to evaluate cumulative effects. Assessments will be conducted at baseline (T0), after the first phase (T1), and after completion of all sessions (T2).
Primary outcome measures include stereopsis (measured in log arcseconds), visual acuity (logMAR), and ocular deviation (prism diopters). Secondary outcomes include sensory and motor characteristics (fusion, suppression, retinal correspondence), treatment adherence, and patient-reported satisfaction and quality of life.
Outcome assessors will be masked to group allocation to reduce bias. The study also aims to explore factors influencing treatment response, including age and type of amblyopia.
This trial seeks to determine whether 3D movie viewing can serve as an effective, engaging, and non-invasive adjunct to conventional amblyopia treatment, with potential implications for improving both visual function and patient adherence.
- Conditions
- Anisometropic Amblyopia, Strabismic Amblyopia
- Being tested
- 3D Movie Viewing, Occlusion Therapy
- Keywords
- Amblyopia, Stereopsis, 3D Movie Viewing, Occlusion Therapy, Strabismus, Anisometropia, Binocular Treatment
- Medical subject headings
- Amblyopia, Strabismus, Anisometropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Movie ViewingBehavioural
Participants will watch 3D movies using active shutter glasses in a controlled environment. Sessions will be conducted once weekly, each lasting approximately 90-120 minutes, over a total of 3 to 6 sessions. This intervention aims to stimulate binocular vision through exposure to large binocular disparities in an immersive and engaging setting.
Occlusion TherapyBehavioural
Standard occlusion therapy of the non-amblyopic eye prescribed according to clinical guidelines and amblyopia severity. Treatment is performed at home for a specified number of hours per day, depending on clinical indication, with the goal of improving visual acuity in the amblyopic eye.
| Study group | Role | What they receive |
|---|---|---|
| 3D Movie Viewing + Occlusion | Experimental | Participants will receive standard occlusion therapy combined with 3D movie viewing sessions. The intervention consists of 3 weekly sessions (Phase 1), followed by 3 additional sessions (Phase 2), each lasting 90-120 minutes, in a controlled environment. Receives: Behavioral: 3D Movie Viewing; Behavioral: Occlusion Therapy |
| Occlusion Therapy | Active comparator | Participants will receive standard occlusion therapy according to clinical guidelines based on amblyopia severity during Phase 1. In Phase 2, participants will also undergo 3D movie viewing sessions. Receives: Behavioral: Occlusion Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stereopsis (RANDOT)
Stereopsis will be assessed using a validated stereopsis test (Random Dot 2 Test). Results will be expressed in log arcseconds.
Measured: Baseline (T0) to 3 weeks (T1)
Change in Visual Acuity
Visual acuity will be measured using standardized ETDRS charts and expressed in logMAR.
Measured: Baseline (T0) to 3 weeks (T1)
Change in Ocular Deviation
Ocular deviation will be assessed using cover test and prism bars at distance (6 m) and near (40 cm), expressed in prism diopters (PD), distinguishing esotropia and exotropia.
Measured: Baseline (T0) to 3 weeks (T1)
Change in Stereopsis ( StereoTAB)
Stereopsis will be assessed using a validated stereopsis test (StereoTAB Test). Results will be expressed in log arcseconds.
Measured: Baseline (T0) to 3 weeks (T1)
Secondary outcomes (4)
Binocular Function (Fusion and Suppression)
Binocular sensory status will be evaluated using the Worth 4 Dot test to assess fusion and suppression.
Measured: Baseline (T0) to 3 weeks (T1)
Retinal Correspondence
Retinal correspondence will be assessed using the Bagolini striated lenses test.
Measured: Baseline (T0) to 3 weeks (T1)
Treatment Adherence
Adherence will be measured as the number of completed sessions and reported hours of occlusion therapy.
Measured: Up to 6 weeks
Adverse Events and Visual Symptoms
Occurrence of symptoms such as headache, visual fatigue, or blurred vision will be recorded using a structured questionnaire.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Jun 2027 (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 Anisometropic 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
- Parallel groups
- Model description
- Participants will be randomized into two parallel groups. The experimental group will receive 3D movie viewing sessions combined with standard occlusion therapy, while the control group will receive occlusion therapy alone during the first phase. In a second phase, all participants will be offered additional 3D viewing sessions to evaluate cumulative effects.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Politècnica de Catalunya
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Mutua de Terrassa
- Responsible party
- Principal investigator, Laura Asensio Jurado, Universitat Politècnica de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563946
- Sponsor's protocol ID
- PDE2LAJ.VISTA3D
- Acronym
- VISTA3D
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bridgeman B. Restoring adult stereopsis: a vision researcher's personal experience. Optom Vis Sci. 2014 Jun;91(6):e135-9. doi: 10.1097/OPX.0000000000000272.
PubMed 24811849Asensio-Jurado L, Argiles M, Quevedo-Junyent L, Mestre C, Levi DM. Can viewing a 3D movie improve visual function in children with a history of amblyopia and neurotypical children?: A pilot study. PLoS One. 2024 Jun 25;19(6):e0305401. doi: 10.1371/journal.pone.0305401. eCollection 2024.
PubMed 38917142
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 3D Movie Viewing Versus Occlusion on Stereopsis and Visual Function in Children With Amblyopia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07563946
- Acronym / sponsor ID
- VISTA3D / PDE2LAJ.VISTA3D
- Conditions
- Anisometropic Amblyopia, Strabismic Amblyopia
- Keywords
- Amblyopia, Stereopsis, 3D Movie Viewing, Occlusion Therapy, Strabismus, Anisometropia, Binocular Treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Universitat Politècnica de CatalunyaUniversity, hospital or other
- Collaborators
- Hospital Mutua de Terrassa
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 4 May 2026 (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 a common childhood visual disorder that affects vision in one eye and can also impair depth perception (stereopsis). Standard treatment typically involves occlusion therapy (patching the stronger eye), which improves visual acuity but often does not fully restore binocular vision.
This study aims to evaluate whether watching 3D movies, combined with occlusion therapy, improves visual outcomes more than occlusion therapy alone in children with amblyopia. The immersive nature of 3D content may stimulate binocular vision and enhance treatment effectiveness.
In this randomized controlled trial, children aged 4 to 14 years with amblyopia will be assigned to one of two groups: one group will receive standard occlusion therapy, while the other will receive occlusion combined with weekly 3D movie sessions. After an initial phase, all participants will have access to 3D viewing sessions.
The study will assess improvements in depth perception, visual acuity, and eye alignment over time. The goal is to determine whether this combined approach provides additional benefits and could be used as a complementary therapy for amblyopia.
Detailed description
Amblyopia is the leading cause of monocular visual impairment in children, with a prevalence of approximately 2-3%. It is commonly associated with strabismus and/or anisometropia and is characterized by reduced visual acuity and deficits in binocular vision, particularly stereopsis. While conventional treatments such as refractive correction and occlusion therapy are effective in improving visual acuity, many patients retain residual deficits in stereopsis and binocular function.
Recent advances in amblyopia treatment have focused on binocular approaches, including perceptual learning, dichoptic training, and virtual reality-based interventions. These methods aim to stimulate binocular interaction and reduce suppression of the amblyopic eye. Among these approaches, 3D movie viewing represents a naturalistic and engaging stimulus that introduces large binocular disparities and may promote binocular integration in a child-friendly environment.
Preliminary evidence from a pilot study conducted by our group demonstrated that a single 3D movie session can produce significant and sustained improvements in stereopsis and visual acuity in children with a history of amblyopia. However, this study lacked a control group and involved only a single exposure session.
The present study is a prospective, randomized, controlled, single-center clinical trial designed to evaluate the efficacy of repeated 3D movie viewing sessions combined with occlusion therapy compared to occlusion therapy alone. Participants will be randomly assigned to either an experimental group (3D viewing plus occlusion) or a control group (occlusion alone). The intervention will consist of 3 to 6 weekly sessions of 3D movie viewing, each lasting approximately 90-120 minutes.
The study includes two phases: an initial comparative phase in which outcomes between groups are assessed after three sessions, and a second phase in which all participants are exposed to additional 3D sessions to evaluate cumulative effects. Assessments will be conducted at baseline (T0), after the first phase (T1), and after completion of all sessions (T2).
Primary outcome measures include stereopsis (measured in log arcseconds), visual acuity (logMAR), and ocular deviation (prism diopters). Secondary outcomes include sensory and motor characteristics (fusion, suppression, retinal correspondence), treatment adherence, and patient-reported satisfaction and quality of life.
Outcome assessors will be masked to group allocation to reduce bias. The study also aims to explore factors influencing treatment response, including age and type of amblyopia.
This trial seeks to determine whether 3D movie viewing can serve as an effective, engaging, and non-invasive adjunct to conventional amblyopia treatment, with potential implications for improving both visual function and patient adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into two parallel groups. The experimental group will receive 3D movie viewing sessions combined with standard occlusion therapy, while the control group will receive occlusion therapy alone during the first phase. In a second phase, all participants will be offered additional 3D viewing sessions to evaluate cumulative effects.
| Arm | Type | Receives |
|---|---|---|
| 3D Movie Viewing + Occlusion | Experimental | Behavioral: 3D Movie Viewing, Behavioral: Occlusion TherapyParticipants will receive standard occlusion therapy combined with 3D movie viewing sessions. The intervention consists of 3 weekly sessions (Phase 1), followed by 3 additional sessions (Phase 2), each lasting 90-120 minutes, in a controlled environment. |
| Occlusion Therapy | Active comparator | Behavioral: Occlusion TherapyParticipants will receive standard occlusion therapy according to clinical guidelines based on amblyopia severity during Phase 1. In Phase 2, participants will also undergo 3D movie viewing sessions. |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 4 to 14 years Diagnosis of unilateral amblyopia (anisometropic, strabismic, or mixed) Interocular visual acuity difference ≥ 0.2 logMAR (equivalent to ≥ 2 Snellen lines) Ability to understand and follow age-appropriate instructions Written informed consent from parents or legal guardians Child assent obtained when applicable
Key exclusion criteria (1 listed)
- Previous treatment for amblyopia Ocular surgery within the last 6 months Strabismus with deviation greater than 10 prism diopters Presence of other ocular pathologies affecting vision (e.g., cataract, nystagmus, ptosis, corneal opacity, retinal disease, optic neuropathy) Neurological or cognitive impairment preventing compliance with study procedures Prior intensive exposure to 3D movies or virtual reality/3D video games that could act as a confounding factor Refusal of the child or family to participate
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 |
|---|---|---|
| 3D Movie ViewingParticipants will watch 3D movies using active shutter glasses in a controlled environment. Sessions will be conducted once weekly, each lasting approximately 90-120 minutes, over a total of 3 to 6 sessions. This intervention aims to stimulate binocular vision through exposure to large binocular disparities in an immersive and engaging setting. | Behavioural | 3D Movie Viewing + Occlusion |
| Occlusion TherapyStandard occlusion therapy of the non-amblyopic eye prescribed according to clinical guidelines and amblyopia severity. Treatment is performed at home for a specified number of hours per day, depending on clinical indication, with the goal of improving visual acuity in the amblyopic eye. | Behavioural | 3D Movie Viewing + Occlusion, Occlusion Therapy |
Primary outcome
Change in Stereopsis (RANDOT)
Time frame: Baseline (T0) to 3 weeks (T1)
Stereopsis will be assessed using a validated stereopsis test (Random Dot 2 Test). Results will be expressed in log arcseconds.
Change in Visual Acuity
Time frame: Baseline (T0) to 3 weeks (T1)
Visual acuity will be measured using standardized ETDRS charts and expressed in logMAR.
Change in Ocular Deviation
Time frame: Baseline (T0) to 3 weeks (T1)
Ocular deviation will be assessed using cover test and prism bars at distance (6 m) and near (40 cm), expressed in prism diopters (PD), distinguishing esotropia and exotropia.
Change in Stereopsis ( StereoTAB)
Time frame: Baseline (T0) to 3 weeks (T1)
Stereopsis will be assessed using a validated stereopsis test (StereoTAB Test). Results will be expressed in log arcseconds.
4 secondary outcomes
Binocular Function (Fusion and Suppression)
Time frame: Baseline (T0) to 3 weeks (T1)
Retinal Correspondence
Time frame: Baseline (T0) to 3 weeks (T1)
Treatment Adherence
Time frame: Up to 6 weeks
Adverse Events and Visual Symptoms
Time frame: Up to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Results publication: PubMed 24811849Bridgeman B. Restoring adult stereopsis: a vision researcher's personal experience. Optom Vis Sci. 2014 Jun;91(6):e135-9. doi: 10.1097/OPX.0000000000000272.
- Results publication: PubMed 38917142Asensio-Jurado L, Argiles M, Quevedo-Junyent L, Mestre C, Levi DM. Can viewing a 3D movie improve visual function in children with a history of amblyopia and neurotypical children?: A pilot study. PLoS One. 2024 Jun 25;19(6):e0305401. doi: 10.1371/journal.pone.0305401. eCollection 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Movie Viewing and Occlusion Therapy in people with Anisometropic Amblyopia and Strabismic Amblyopia, run by Universitat Politècnica de Catalunya.
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: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Asensio Jurado, PhD (0034636760450, asensiojlaura@upc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Stereopsis (RANDOT) (time frame: Baseline (T0) to 3 weeks (T1)). The study lists 4 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 NCT07563946, 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 4 May 2026.