search
Back to results

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

Primary Purpose

Amblyopia, Anisometropic Amblyopia, Strabismic Amblyopia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
3D movie viewing
Sponsored by
Universitat Politècnica de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia focused on measuring 3D movies, Amblyopia treatment

Eligibility Criteria

5 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Laura Asensio Jurado

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

3D movie

Arm Description

3D movie viewing

Outcomes

Primary Outcome Measures

Change from baseline Stereopsis, immediately after intervention and at 3 months studying the effect of viewing a 3D movie on visual function.
Stereopsis (ST in logMAR) will be evaluated by a TNO test.
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.
Latent o manifest deviation will be evaluated at 6 m and will be measured by prisms.
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.
Latent o manifest deviation will be evaluated at 40cm and will be measured by prisms.

Secondary Outcome Measures

Satisfaction assessed by an ordinal questionnaire designed based on the Treatment Satisfaction Questionnaire for Medication (TSQM).
Satisfaction assessed by an ordinal questionnaire (1 to 5, as 1 the lowest satisfaction and 5 the highest satisfaction), based on the TSQM (Treatment Satisfaction Questionnaire for Medication) version 1.4 to provide data regarding the degree of satisfaction and sensation of parents and children in relation to treatment.

Full Information

First Posted
March 16, 2020
Last Updated
December 20, 2022
Sponsor
Universitat Politècnica de Catalunya
Collaborators
Hospital Mutua de Terrassa
search

1. Study Identification

Unique Protocol Identification Number
NCT04315649
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 16, 2021 (Actual)
Primary Completion Date
March 19, 2022 (Actual)
Study Completion Date
May 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitat Politècnica de Catalunya
Collaborators
Hospital Mutua de Terrassa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia, Anisometropic Amblyopia, Strabismic Amblyopia
Keywords
3D movies, Amblyopia treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3D movie
Arm Type
Experimental
Arm Description
3D movie viewing
Intervention Type
Other
Intervention Name(s)
3D movie viewing
Intervention Description
3D movie viewing
Primary Outcome Measure Information:
Title
Change from baseline Stereopsis, immediately after intervention and at 3 months studying the effect of viewing a 3D movie on visual function.
Description
Stereopsis (ST in logMAR) will be evaluated by a TNO test.
Time Frame
Baseline, immediately after intervention and 3 months
Title
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.
Description
Latent o manifest deviation will be evaluated at 6 m and will be measured by prisms.
Time Frame
Baseline, immediately after intervention and 3 months
Title
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.
Description
Latent o manifest deviation will be evaluated at 40cm and will be measured by prisms.
Time Frame
Baseline, immediately after intervention and 3 months
Secondary Outcome Measure Information:
Title
Satisfaction assessed by an ordinal questionnaire designed based on the Treatment Satisfaction Questionnaire for Medication (TSQM).
Description
Satisfaction assessed by an ordinal questionnaire (1 to 5, as 1 the lowest satisfaction and 5 the highest satisfaction), based on the TSQM (Treatment Satisfaction Questionnaire for Medication) version 1.4 to provide data regarding the degree of satisfaction and sensation of parents and children in relation to treatment.
Time Frame
Immediately after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Asensio Jurado, MsC
Organizational Affiliation
Universitat Politècnica de Catalunya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc Argilés Sans, PhD
Organizational Affiliation
Universitat Politècnica de Catalunya
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lluïsa Quevedo i Junyent, PhD
Organizational Affiliation
Universitat Politècnica de Catalunya
Official's Role
Study Director
Facility Information:
Facility Name
Laura Asensio Jurado
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24811849
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.
Results Reference
background
PubMed Identifier
25637854
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.
Results Reference
background
PubMed Identifier
29779684
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.
Results Reference
background
PubMed Identifier
31103562
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.
Results Reference
background
PubMed Identifier
28614556
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs