Clinical trial NCT04315649: Effect of 3D Movie Viewing on Stereopsis in Strabismus and / or Anisometropic Amblyops
Official title: Effect of 3D Movie Viewing on Stereopsis in Strabismus and / or Anisometropic Amblyops
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amblyopia
Anisometropic Amblyopia
Strabismic Amblyopia
Keywords: 3D movies
Amblyopia treatment
Lead sponsor: Universitat Politècnica de Catalunya
Sponsor class: OTHER
Collaborators: name: Hospital Mutua de Terrassa
First posted: 2020-03-19
Enrollment: 24
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of 3D movie viewing on stereopsis recovery in anisometropic and / or strabismus amblyopia and the satisfaction with the intervention.

Detailed description: Amblyopia is a visual neurodevelopmental disorder associated, more frequently, with the presence of strabismus and anisometropia. It is clinically most important visual condition in childhood because, apart from refractive error, it is the most frequent cause of vision loss in children. It is a reversible condition that affects up to 5% of the population, and that is the result of an abnormal visual experience during the most sensitive period of visual development. Although amblyopia is expressed in the clinical practice as a reduction in visual acuity, it is also characterized by an altered stereoscopy. Generally, treatments for amblyopia focus on the recovery of visual acuity, and there are no treatments that focus mainly on the recovery of the altered stereopsis, so present and with an important functional impact.

The aim of this study reviewing, analyzing and, if applicable, updating the current treatment model for amblyopia. On the one hand, to evaluate the effectiveness of viewing a 3D movie in the improvement of stereoacuity and the deviation, as well as visual acuity and sensitivity to contrast. Also, the correlation between them. On the other hand, to assess quantitatively the degree of satisfaction and acceptance of the participants and their families towards the intervention.

A quasi-experimental study will be performed, without a control group, pre- and post- intervention in which subjects with refractive and / or strabismus amblyopia, that have been subjected to traditional treatment for amblyopia, will be selected. Variables of stereopsis, latent or manifest deviation, visual acuity and sensitivity to the contrast will evaluate previously and after the intervention.

The sample will include subjects between 5 to 12 years old with a diagnosis of refractive and / or strabismic amblyopia.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of refractive and / or strabismus amblyopia at some point in life
* History of amblyopia treatment completed at least 6 months before the intervention
* Deviation angle equal to or less than 10 Dp
* Absence of associated ophthalmological pathology.

Exclusion Criteria:

* Ongoing amblyopia treatment;
* Non-comitant and/or large constant strabismus (\>10 prism diopters)
* Any ocular pathological condition or nystagmus.

Primary outcomes:
measure: Change from baseline Stereopsis, immediately after intervention and at 3 months studying the effect of viewing a 3D movie on visual function.
timeFrame: Baseline, immediately after intervention and 3 months
measure: Change from baseline latent or manifest deviation at 6m, immediately after intervention and 3 months studying the effect of viewing a 3D movie in the visual function.
timeFrame: Baseline, immediately after intervention and 3 months
measure: Change from baseline latent or manifest deviation at 40cm, after intervention at and 3 months studying the effect of viewing a 3D movie in the visual function.
timeFrame: Baseline, immediately after intervention and 3 months
Secondary outcomes:
measure: Satisfaction assessed by an ordinal questionnaire designed based on the Treatment Satisfaction Questionnaire for Medication (TSQM).
timeFrame: Immediately after intervention
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Laura Asensio Jurado
Study officials:
affiliation: Universitat Politècnica de Catalunya
name: Laura Asensio Jurado, MsC
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat Politècnica de Catalunya
name: Marc Argilés Sans, PhD
role: STUDY_DIRECTOR
affiliation: Universitat Politècnica de Catalunya
name: Lluïsa Quevedo i Junyent, PhD
role: STUDY_DIRECTOR
References:
citation: Bridgeman B. Restoring adult stereopsis: a vision researcher's personal experience. Optom Vis Sci. 2014 Jun;91(6):e135-9. doi: 10.1097/OPX.0000000000000272.
citation: Levi DM, Knill DC, Bavelier D. Stereopsis and amblyopia: A mini-review. Vision Res. 2015 Sep;114:17-30. doi: 10.1016/j.visres.2015.01.002. Epub 2015 Jan 29.
citation: Li RW, Tran KD, Bui JK, Antonucci MM, Ngo CV, Levi DM. Improving Adult Amblyopic Vision with Stereoscopic 3-Dimensional Video Games. Ophthalmology. 2018 Oct;125(10):1660-1662. doi: 10.1016/j.ophtha.2018.04.025. Epub 2018 May 18. No abstract available.
citation: Birch EE, Jost RM, De La Cruz A, Kelly KR, Beauchamp CL, Dao L, Stager D Jr, Leffler JN. Binocular amblyopia treatment with contrast-rebalanced movies. J AAPOS. 2019 Jun;23(3):160.e1-160.e5. doi: 10.1016/j.jaapos.2019.02.007. Epub 2019 May 16.
citation: Bossi M, Tailor VK, Anderson EJ, Bex PJ, Greenwood JA, Dahlmann-Noor A, Dakin SC. Binocular Therapy for Childhood Amblyopia Improves Vision Without Breaking Interocular Suppression. Invest Ophthalmol Vis Sci. 2017 Jun 1;58(7):3031-3043. doi: 10.1167/iovs.16-20913.