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

NCT ID: NCT07301645

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2026-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

3D Movie Viewing

Group Type: EXPERIMENTAL

Stereoscopic (3D) Movie Viewing

Intervention Type: 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).

2D Movie Viewing

Group Type: ACTIVE_COMPARATOR

2D Movie Viewing

Intervention Type: 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).

Interventions

Stereoscopic (3D) Movie Viewing

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).

Intervention Type: BEHAVIORAL

2D Movie Viewing

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Mutua Terrassa

UNKNOWN

Sponsor Role: collaborator

Universitat Politècnica de Catalunya

OTHER

Sponsor Role: lead

Responsible Party

Laura Asensio Jurado

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Laura Asensio Jurado, PhD

Role: CONTACT

Phone: 0034636764050

Email: laura.asensio@upc.edu

References

Mohan V. Dietary fibre and ischaemic heart disease. J Assoc Physicians India. 2000 Sep;48(9):869-70. No abstract available.

Reference Type: RESULT

PMID: 11198783 (View on PubMed)

Other Identifiers

PDE1LAJ.VISION3D

Identifier Type: -

Identifier Source: org_study_id