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Effect of 3D Movie Viewing on Stereopsis in Strabismus and / or Anisometropic Amblyops

NCT ID: NCT04315649

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-16

Study Completion Date

2022-05-20

Brief Summary

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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

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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.

Conditions

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Amblyopia Anisometropic Amblyopia Strabismic Amblyopia

Keywords

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3D movies Amblyopia treatment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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3D movie

3D movie viewing

Group Type EXPERIMENTAL

3D movie viewing

Intervention Type OTHER

3D movie viewing

Interventions

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3D movie viewing

3D movie viewing

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Mutua de Terrassa

OTHER

Sponsor Role collaborator

Universitat Politècnica de Catalunya

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Asensio Jurado, MsC

Role: PRINCIPAL_INVESTIGATOR

Universitat Politècnica de Catalunya

Marc Argilés Sans, PhD

Role: STUDY_DIRECTOR

Universitat Politècnica de Catalunya

Lluïsa Quevedo i Junyent, PhD

Role: STUDY_DIRECTOR

Universitat Politècnica de Catalunya

Locations

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Laura Asensio Jurado

Barcelona, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 24811849 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25637854 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29779684 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31103562 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28614556 (View on PubMed)

Other Identifiers

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PhDLAJE2

Identifier Type: -

Identifier Source: org_study_id