VISION-3D: Visual Skills Improvement With On-screen 3D Movies.

NCT07301645 | Not Yet Recruiting

• 1 other identifier: PDE1LAJ.VISION3D
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Amblyopia; Strabismus

Keywords

Amblyopia; Strabismus; Cinema 3D

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  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).

  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.

  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

  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

  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

  Post-Phase 1 (T1, Week 3), post-Phase 2 (T2, Week 6).

Study Arms (2)

3D Movie Viewing

EXPERIMENTAL

Behavioral: Stereoscopic (3D) Movie Viewing

2D Movie Viewing

ACTIVE COMPARATOR

Behavioral: 2D Movie Viewing

Interventions

Stereoscopic (3D) Movie Viewing BEHAVIORAL

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).

3D Movie Viewing

2D Movie Viewing BEHAVIORAL

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).

2D Movie Viewing

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat Politècnica de Catalunya: lead
• Hospital Universitari Mutua Terrassa: collaborator

Related Publications (1)

• 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.

  PMID: 38917142 RESULT

MeSH Terms

Conditions

Amblyopia; Strabismus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ocular Motility Disorders; Cranial Nerve Diseases

Central Study Contacts

Laura Asensio Jurado, PhD

CONTACT

0034636764050; laura.asensio@upc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized parallel-group with delayed-treatment (wait-list) extension.

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 24, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share