3D Movie Viewing vs Occlusion for Treating Amblyopia in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-14
SponsorUniversitat Politècnica de Catalunya
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
3D Movie Viewing
BehavioralParticipants 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.
Occlusion Therapy
BehavioralStandard 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.
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: 3D Movie Viewing + OcclusionExperimental treatment 2 interventions
Group B: Occlusion TherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Stereopsis (RANDOT)
Stereopsis will be assessed using a validated stereopsis test (Random Dot 2 Test). Results will be expressed in log arcseconds.
Time frame
Baseline (T0) to 3 weeks (T1)2
Change in Visual Acuity
Visual acuity will be measured using standardized ETDRS charts and expressed in logMAR.
Time frame
Baseline (T0) to 3 weeks (T1)3
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.
Time frame
Baseline (T0) to 3 weeks (T1)4
Change in Stereopsis ( StereoTAB)
Stereopsis will be assessed using a validated stereopsis test (StereoTAB Test). Results will be expressed in log arcseconds.
Time frame
Baseline (T0) to 3 weeks (T1)Secondary outcomes
1
Binocular Function (Fusion and Suppression)
Binocular sensory status will be evaluated using the Worth 4 Dot test to assess fusion and suppression.
Time frame
Baseline (T0) to 3 weeks (T1)2
Retinal Correspondence
Retinal correspondence will be assessed using the Bagolini striated lenses test.
Time frame
Baseline (T0) to 3 weeks (T1)3
Treatment Adherence
Adherence will be measured as the number of completed sessions and reported hours of occlusion therapy.
Time frame
Up to 6 weeks4
Adverse Events and Visual Symptoms
Occurrence of symptoms such as headache, visual fatigue, or blurred vision will be recorded using a structured questionnaire.
Time frame
Up to 6 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universitat Politècnica de Catalunya
Lead sponsor
Hospital Mutua de Terrassa
Collaborator
Source ClinicalTrials.gov
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