AmblyopiaVISION3DNCT07301645
VISION-3D: Visual Skills Improvement With On-screen 3D Movies.
A study testing Stereoscopic (3D) Movie Viewing and 2D Movie Viewing in people with Amblyopia and Strabismus, run by Universitat Politècnica de Catalunya.
Trial summary
This clinical study investigates whether watching 3D films can help improve the vision of children with residual amblyopia (lazy eye), that is, those children who, despite having undergone usual treatments such as glasses or patching, still maintain some visual deficit. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Amblyopia, Strabismus
- What is being tested?
- Stereoscopic (3D) Movie Viewing and 2D Movie Viewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2026to Jul 2026
- 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 12 years.
- Previous diagnosis of unilateral amblyopia (anisometropic, strabismic, or mixed).
- History of conventional treatment (optical correction, occlusion and/or penalization) with stable visual acuity for at least 6 months.
- Interocular visual acuity difference ≥ 0.2 logMAR (≈ ≥2 Snellen lines).
- Ability to understand and follow age-appropriate basic instructions.
- Parent/guardian consent (and child assent when applicable)
Who cannot join
- Ocular surgery within the last 6 months.
- Manifest strabismus >15 prism diopters.
- Concomitant ocular pathology that may affect vision (e.g., cataract, nystagmus, ptosis, corneal opacity, retinal disease, optic neuropathy).
- Cognitive or neurological deficits preventing compliance with the protocol.
- Prior intensive exposure to 3D cinema or VR/3D videogames that could act as a confounder.
- Family or child refusal 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 Versus 2D Movie Viewing on Stereopsis and Visual Function in Children With Residual Ambliopia. A Randomized Controlled Trial.
This clinical study investigates whether watching 3D films can help improve the vision of children with residual amblyopia (lazy eye), that is, those children who, despite having undergone usual treatments such as glasses or patching, still maintain some visual deficit. The main objective is to verify whether viewing in 3D is better than viewing in 2D in improving depth vision (stereopsis), visual acuity and ocular alignment. The hypothesis is that 3D films, by providing richer binocular stimuli, will produce greater improvements than the same 2D films.
Children between 4 and 14 years of age with residual, stable and previously treated unilateral amblyopia will be included. Participants will be recruited from the pediatric ophthalmology/optometry clinics of the Mútua University Hospital
Read more
The study will be conducted in two locations: the visual examinations will be performed at the Mútua University Hospital in Terrassa, and the film sessions at the Faculty of Optics and Optometry of Terrassa (FOOT, UPC), in rooms prepared with a projector and 3D glasses.
The design is randomized and controlled. In a first phase, the children will be randomly divided into two groups: one group will watch 3 films in 3D and the other will watch the same films in 2D. Then, in a second phase, all participants will watch 3 additional sessions in 3D. Four evaluation visits will be made: before starting, after phase 1, after phase 2 and a follow-up two months later. These visits will measure stereopsis, visual acuity, and ocular deviation with standard optometric tests.
Watching 3D movies is a safe and non-invasive activity; therefore, no significant risks are expected beyond some possible mild and transient discomfort such as eye strain or headache, which will be recorded if it occurs. Potential benefits include improved depth perception and other visual functions, and the results could open the door to new, fun and motivating therapeutic options for other children with amblyopia in the future.
- Conditions
- Amblyopia, Strabismus
- Being tested
- Stereoscopic (3D) Movie Viewing, 2D Movie Viewing
- Keywords
- Amblyopia, Strabismus, Cinema 3D
- Medical subject headings
- Amblyopia, Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereoscopic (3D) Movie ViewingBehavioural
Repeated binocular visual stimulation. Participants view age-appropriate commercial films under standardized conditions once a week for three consecutive weeks in Phase 1. In the experimental intervention, the films are viewed in stereoscopic 3D using active shutter glasses and a calibrated 3D projection system. Each session lasts 90-120 minutes. After Phase 1, all participants receive three additional weekly 3D sessions (delayed treatment extension).
2D Movie ViewingBehavioural
Repeated binocular visual stimulation. Participants view age-appropriate commercial films under standardized conditions once a week for three consecutive weeks in Phase 1. In the control intervention, the films are viewed in 2D with identical duration and setting. Each session lasts 90-120 minutes. After Phase 1, all participants receive three additional weekly 3D sessions (delayed treatment extension).
| Study group | Role | What they receive |
|---|---|---|
| 3D Movie Viewing | Experimental | Not described Receives: Behavioral: Stereoscopic (3D) Movie Viewing |
| 2D Movie Viewing | Active comparator | Not described Receives: Behavioral: 2D Movie Viewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in stereoacuity measured with the Random Dot 2 Stereo Test (log arcsec)
Stereoacuity will be assessed using the validated Random Dot 2 Stereo Test. Results will be recorded in arcseconds and analyzed as log arcsec. The primary endpoint is the change from baseline (T0) to each post-intervention assessment (T1 and T2) and follow-up (T3).
Measured: Baseline (T0, Week 0), post-Phase 1 (T1, Week 3), post-Phase 2 (T2, Week 6), and follow-up (T3, 2 months after Phase 2)
Change from baseline in best-corrected visual acuity (BCVA) of the amblyopic eye measured with ETDRS (logMAR)
Best-corrected visual acuity of the amblyopic eye will be assessed using standardized ETDRS optotypes with the participant wearing habitual optical correction. Visual acuity will be recorded in logMAR. The outcome is the change in BCVA from baseline (T0) to each post-intervention assessment (T1 and T2) and follow-up (T3).
Measured: Baseline (T0, Week 0), post-Phase 1 (T1, Week 3), post-Phase 2 (T2, Week 6), and follow-up (T3, 2 months after Phase 2).
Change from baseline in ocular deviation measured by cover test with prism bars at distance (6 m) and near (40 cm) (prism diopters)
Ocular deviation will be assessed using the cover test with prism bars at distance (6 m) and near (40 cm). The magnitude and direction of deviation will be recorded in prism diopters (PD/DP), distinguishing esotropia and exotropia when present. The outcome is the change in ocular deviation from baseline (T0) to each post-intervention assessment (T1 and T2) and follow-up (T3).
Measured: Baseline (T0, Week 0), post-Phase 1 (T1, Week 3), post-Phase 2 (T2, Week 6), and follow-up (T3, 2 months after Phase 2)
Secondary outcomes (4)
Change from baseline in binocular sensory status (suppression/fusion) measured by the Worth 4 Dot test at distance and near.
Binocular sensory status will be assessed using the Worth 4 Dot test at distance and near. Participants will be classified as showing fusion or suppression (and, if applicable, diplopia) based on standard Worth 4 Dot criteria. The outcome is the change in binocular sensory status from baseline (T0) to post-intervention assessments (T1 and T2) and follow-up (T3).
Measured: Baseline (T0, Week 0), post-Phase 1 (T1, Week 3), post-Phase 2 (T2, Week 6), and follow-up (T3, 2 months after Phase 2).
Retinal correspondence status assessed by the Bagolini striated lens test
Retinal correspondence will be evaluated using the Bagolini striated lens test under standard clinical conditions. Participants will be classified as showing normal retinal correspondence, anomalous retinal correspondence, or suppression according to Bagolini response patterns. Results will be reported at each assessment time point.
Measured: Baseline (T0, Week 0), post-Phase 1 (T1, Week 3), post-Phase 2 (T2, Week 6), and follow-up (T3, 2 months after Phase 2)
Vision-related quality of life measured by the Pediatric Eye Questionnaire (PedEyeQ) total score
Vision-related quality of life will be assessed using the age-appropriate PedEyeQ modules (child self-report and/or parent-proxy, plus parent component). Total PedEyeQ scores will be calculated according to the scoring manual and reported at each assessment time point.
Measured: Baseline (T0, Week 0), post-Phase 1 (T1, Week 3), post-Phase 2 (T2, Week 6).
Participant/family satisfaction with the intervention measured by a study-specific Likert satisfaction questionnaire
Participant/family satisfaction will be measured using a structured study-specific questionnaire with Likert-type items (e.g., enjoyment, comfort, perceived benefit, and willingness to repeat). Satisfaction scores will be summarized and reported by group at each post-intervention time point.
Measured: Post-Phase 1 (T1, Week 3), post-Phase 2 (T2, Week 6).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start15 Jan 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Parallel groups
- Model description
- Randomized parallel-group with delayed-treatment (wait-list) extension.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 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
- NCT07301645
- Sponsor's protocol ID
- PDE1LAJ.VISION3D
- Acronym
- VISION3D
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asensio-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 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 3D Versus 2D Movie Viewing on Stereopsis and Visual Function in Children With Residual Ambliopia. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07301645
- Acronym / sponsor ID
- VISION3D / PDE1LAJ.VISION3D
- Conditions
- Amblyopia, Strabismus
- Keywords
- Amblyopia, Strabismus, Cinema 3D
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitat Politècnica de CatalunyaUniversity, hospital or other
- Collaborators
- Hospital Mutua de Terrassa
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 24 Dec 2025 (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.
This clinical study investigates whether watching 3D films can help improve the vision of children with residual amblyopia (lazy eye), that is, those children who, despite having undergone usual treatments such as glasses or patching, still maintain some visual deficit. The main objective is to verify whether viewing in 3D is better than viewing in 2D in improving depth vision (stereopsis), visual acuity and ocular alignment. The hypothesis is that 3D films, by providing richer binocular stimuli, will produce greater improvements than the same 2D films.
Children between 4 and 14 years of age with residual, stable and previously treated unilateral amblyopia will be included. Participants will be recruited from the pediatric ophthalmology/optometry clinics of the Mútua University Hospital
The study will be conducted in two locations: the visual examinations will be performed at the Mútua University Hospital in Terrassa, and the film sessions at the Faculty of Optics and Optometry of Terrassa (FOOT, UPC), in rooms prepared with a projector and 3D glasses.
The design is randomized and controlled. In a first phase, the children will be randomly divided into two groups: one group will watch 3 films in 3D and the other will watch the same films in 2D. Then, in a second phase, all participants will watch 3 additional sessions in 3D. Four evaluation visits will be made: before starting, after phase 1, after phase 2 and a follow-up two months later. These visits will measure stereopsis, visual acuity, and ocular deviation with standard optometric tests.
Watching 3D movies is a safe and non-invasive activity; therefore, no significant risks are expected beyond some possible mild and transient discomfort such as eye strain or headache, which will be recorded if it occurs. Potential benefits include improved depth perception and other visual functions, and the results could open the door to new, fun and motivating therapeutic options for other children with amblyopia in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized parallel-group with delayed-treatment (wait-list) extension.
| Arm | Type | Receives |
|---|---|---|
| 3D Movie Viewing | Experimental | Behavioral: Stereoscopic (3D) Movie Viewing |
| 2D Movie Viewing | Active comparator | Behavioral: 2D Movie Viewing |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 4 to 12 years.
- Previous diagnosis of unilateral amblyopia (anisometropic, strabismic, or mixed).
- History of conventional treatment (optical correction, occlusion and/or penalization) with stable visual acuity for at least 6 months.
- Interocular visual acuity difference ≥ 0.2 logMAR (≈ ≥2 Snellen lines).
- Ability to understand and follow age-appropriate basic instructions.
Key exclusion criteria (6 listed)
- Ocular surgery within the last 6 months.
- Manifest strabismus >15 prism diopters.
- Concomitant ocular pathology that may affect vision (e.g., cataract, nystagmus, ptosis, corneal opacity, retinal disease, optic neuropathy).
- Cognitive or neurological deficits preventing compliance with the protocol.
- Prior intensive exposure to 3D cinema or VR/3D videogames that could act as a confounder.
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 |
|---|---|---|
| Stereoscopic (3D) Movie ViewingRepeated binocular visual stimulation. Participants view age-appropriate commercial films under standardized conditions once a week for three consecutive weeks in Phase 1. In the experimental intervention, the films are viewed in stereoscopic 3D using active shutter glasses and a calibrated 3D projection system. Each session lasts 90-120 minutes. After Phase 1, all participants receive three additional weekly 3D sessions (delayed treatment extension). | Behavioural | 3D Movie Viewing |
| 2D Movie ViewingRepeated binocular visual stimulation. Participants view age-appropriate commercial films under standardized conditions once a week for three consecutive weeks in Phase 1. In the control intervention, the films are viewed in 2D with identical duration and setting. Each session lasts 90-120 minutes. After Phase 1, all participants receive three additional weekly 3D sessions (delayed treatment extension). | Behavioural | 2D Movie Viewing |
Primary outcome
Change from baseline in stereoacuity measured with the Random Dot 2 Stereo Test (log arcsec)
Time frame: Baseline (T0, Week 0), post-Phase 1 (T1, Week 3), post-Phase 2 (T2, Week 6), and follow-up (T3, 2 months after Phase 2)
Stereoacuity will be assessed using the validated Random Dot 2 Stereo Test. Results will be recorded in arcseconds and analyzed as log arcsec. The primary endpoint is the change from baseline (T0) to each post-intervention assessment (T1 and T2) and follow-up (T3).
Change from baseline in best-corrected visual acuity (BCVA) of the amblyopic eye measured with ETDRS (logMAR)
Time frame: Baseline (T0, Week 0), post-Phase 1 (T1, Week 3), post-Phase 2 (T2, Week 6), and follow-up (T3, 2 months after Phase 2).
Best-corrected visual acuity of the amblyopic eye will be assessed using standardized ETDRS optotypes with the participant wearing habitual optical correction. Visual acuity will be recorded in logMAR. The outcome is the change in BCVA from baseline (T0) to each post-intervention assessment (T1 and T2) and follow-up (T3).
Change from baseline in ocular deviation measured by cover test with prism bars at distance (6 m) and near (40 cm) (prism diopters)
Time frame: Baseline (T0, Week 0), post-Phase 1 (T1, Week 3), post-Phase 2 (T2, Week 6), and follow-up (T3, 2 months after Phase 2)
Ocular deviation will be assessed using the cover test with prism bars at distance (6 m) and near (40 cm). The magnitude and direction of deviation will be recorded in prism diopters (PD/DP), distinguishing esotropia and exotropia when present. The outcome is the change in ocular deviation from baseline (T0) to each post-intervention assessment (T1 and T2) and follow-up (T3).
4 secondary outcomes
Change from baseline in binocular sensory status (suppression/fusion) measured by the Worth 4 Dot test at distance and near.
Time frame: Baseline (T0, Week 0), post-Phase 1 (T1, Week 3), post-Phase 2 (T2, Week 6), and follow-up (T3, 2 months after Phase 2).
Retinal correspondence status assessed by the Bagolini striated lens test
Time frame: Baseline (T0, Week 0), post-Phase 1 (T1, Week 3), post-Phase 2 (T2, Week 6), and follow-up (T3, 2 months after Phase 2)
Vision-related quality of life measured by the Pediatric Eye Questionnaire (PedEyeQ) total score
Time frame: Baseline (T0, Week 0), post-Phase 1 (T1, Week 3), post-Phase 2 (T2, Week 6).
Participant/family satisfaction with the intervention measured by a study-specific Likert satisfaction questionnaire
Time frame: Post-Phase 1 (T1, Week 3), post-Phase 2 (T2, Week 6).
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 24 Dec 2025.
- 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: 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.
Questions about this trial
What is this clinical trial studying?
A study testing Stereoscopic (3D) Movie Viewing and 2D Movie Viewing in people with Amblyopia and Strabismus, 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 6 inclusion and 6 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 24 Dec 2025. 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 (0034636764050, laura.asensio@upc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in stereoacuity measured with the Random Dot 2 Stereo Test (log arcsec) (time frame: Baseline (T0, Week 0), post-Phase 1 (T1, Week 3), post-Phase 2 (T2, Week 6), and follow-up (T3, 2 months after Phase 2)). The study lists 3 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 NCT07301645, which also lists 1 linked publication.
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 24 Dec 2025.