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Not Yet RecruitingNCT07301645

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

Efficacy of 3D Versus 2D Movie Viewing on Stereopsis and Visual Function in Children With Residual Ambliopia. A Randomized Controlled Trial.

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Universitat Politècnica de Catalunya · Academic / Other
Sex
All
Age
4 Years – 14 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALStereoscopic (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).
BEHAVIORAL2D 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).

Timeline

Start date
2026-01-15
Primary completion
2026-07-01
Completion
2026-07-01
First posted
2025-12-24
Last updated
2025-12-24

Source: ClinicalTrials.gov record NCT07301645. Inclusion in this directory is not an endorsement.