Efficacy of 3D Movie Viewing Versus Occlusion on Stereopsis and Visual Function in Children With Amblyopia: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 56
- Primary Endpoint
- Change in Stereopsis (RANDOT)
Study Overview
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.
Detailed Description
Amblyopia is the leading cause of monocular visual impairment in children, with a prevalence of approximately 2-3%. It is commonly associated with strabismus and/or anisometropia and is characterized by reduced visual acuity and deficits in binocular vision, particularly stereopsis. While conventional treatments such as refractive correction and occlusion therapy are effective in improving visual acuity, many patients retain residual deficits in stereopsis and binocular function.
Recent advances in amblyopia treatment have focused on binocular approaches, including perceptual learning, dichoptic training, and virtual reality-based interventions. These methods aim to stimulate binocular interaction and reduce suppression of the amblyopic eye. Among these approaches, 3D movie viewing represents a naturalistic and engaging stimulus that introduces large binocular disparities and may promote binocular integration in a child-friendly environment.
Preliminary evidence from a pilot study conducted by our group demonstrated that a single 3D movie session can produce significant and sustained improvements in stereopsis and visual acuity in children with a history of amblyopia. However, this study lacked a control group and involved only a single exposure session.
The present study is a prospective, randomized, controlled, single-center clinical trial designed to evaluate the efficacy of repeated 3D movie viewing sessions combined with occlusion therapy compared to occlusion therapy alone. Participants will be randomly assigned to either an experimental group (3D viewing plus occlusion) or a control group (occlusion alone). The intervention will consist of 3 to 6 weekly sessions of 3D movie viewing, each lasting approximately 90-120 minutes.
The study includes two phases: an initial comparative phase in which outcomes between groups are assessed after three sessions, and a second phase in which all participants are exposed to additional 3D sessions to evaluate cumulative effects. Assessments will be conducted at baseline (T0), after the first phase (T1), and after completion of all sessions (T2).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 4 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
3D Movie Viewing + Occlusion
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.
Intervention: 3D Movie Viewing (Behavioral)
3D Movie Viewing + Occlusion
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.
Intervention: Occlusion Therapy (Behavioral)
Occlusion Therapy
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.
Intervention: Occlusion Therapy (Behavioral)
Outcomes
Primary Outcomes
Change in Stereopsis (RANDOT)
Time Frame: Baseline (T0) to 3 weeks (T1)
Stereopsis will be assessed using a validated stereopsis test (Random Dot 2 Test). Results will be expressed in log arcseconds.
Change in Visual Acuity
Time Frame: Baseline (T0) to 3 weeks (T1)
Visual acuity will be measured using standardized ETDRS charts and expressed in logMAR.
Change in Ocular Deviation
Time Frame: Baseline (T0) to 3 weeks (T1)
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.
Change in Stereopsis ( StereoTAB)
Time Frame: Baseline (T0) to 3 weeks (T1)
Stereopsis will be assessed using a validated stereopsis test (StereoTAB Test). Results will be expressed in log arcseconds.
Secondary Outcomes
- 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)
Investigators
Laura Asensio Jurado
PhD
Universitat Politècnica de Catalunya