3D Movie Viewing vs Occlusion for Treating Amblyopia in Children

NCT07563946 | Not Yet Recruiting

• 1 other identifier: PDE2LAJ.VISTA3D
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Anisometropic Amblyopia; Strabismic Amblyopia

Keywords

Amblyopia; Stereopsis; 3D Movie Viewing; Occlusion Therapy; Strabismus; Anisometropia; Binocular Treatment

Outcome Measures

Primary Outcomes (4)

• Change in Stereopsis (RANDOT)

  Stereopsis will be assessed using a validated stereopsis test (Random Dot 2 Test). Results will be expressed in log arcseconds.

  Baseline (T0) to 3 weeks (T1)

• Change in Visual Acuity

  Visual acuity will be measured using standardized ETDRS charts and expressed in logMAR.

  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.

  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.

  Baseline (T0) to 3 weeks (T1)

Secondary Outcomes (4)

• Binocular Function (Fusion and Suppression)

  Baseline (T0) to 3 weeks (T1)

• Retinal Correspondence

  Baseline (T0) to 3 weeks (T1)

• Treatment Adherence

  Up to 6 weeks

• Adverse Events and Visual Symptoms

  Up to 6 weeks

Study Arms (2)

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.

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.

Behavioral: Occlusion Therapy

Interventions

3D Movie Viewing BEHAVIORAL

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.

3D Movie Viewing + Occlusion

Occlusion Therapy BEHAVIORAL

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.

3D Movie Viewing + Occlusion; Occlusion Therapy

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Related Publications (2)

• Bridgeman B. Restoring adult stereopsis: a vision researcher's personal experience. Optom Vis Sci. Jun 2014;91(6):e135-9. doi:https://doi.org/10.1097/opx.0000000000000272

  RESULT

• Asensio-Jurado L, Argilés 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;19(6):e0305401. doi:https://doi.org/10.1371/journal.pone.0305401

  RESULT

MeSH Terms

Conditions

Amblyopia; Strabismus; Anisometropia

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; Refractive Errors

Central Study Contacts

Laura Asensio Jurado, PhD

CONTACT

0034636760450; asensiojlaura@upc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors (optometrists/ophthalmologists) will be masked to group allocation and assessment time points (baseline, post-intervention, and follow-up). Participants and caregivers will not be masked due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04