NCT04315649

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2020

Completed
1.5 years until next milestone

Study Start

First participant enrolled

September 16, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2022

Completed
Last Updated

December 23, 2022

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

March 16, 2020

Last Update Submit

December 20, 2022

Conditions

AmblyopiaAnisometropic AmblyopiaStrabismic Amblyopia

Keywords

3D moviesAmblyopia treatment

Outcome Measures

Primary Outcomes (3)

  • 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.

    Baseline, immediately after intervention and 3 months

  • 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.

    Baseline, immediately after intervention and 3 months

  • 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.

    Baseline, immediately after intervention and 3 months

Secondary Outcomes (1)

  • Satisfaction assessed by an ordinal questionnaire designed based on the Treatment Satisfaction Questionnaire for Medication (TSQM).

    Immediately after intervention

Study Arms (1)

3D movie

EXPERIMENTAL

3D movie viewing

Other: 3D movie viewing

Interventions

3D movie viewingOTHER

3D movie viewing

3D movie

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laura Asensio Jurado

Barcelona, Spain

Location

Related Publications (5)

  • 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.

    PMID: 24811849BACKGROUND

  • 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.

    PMID: 25637854BACKGROUND

  • 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.

    PMID: 29779684BACKGROUND

  • 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.

    PMID: 31103562BACKGROUND

  • 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.

    PMID: 28614556BACKGROUND

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Laura Asensio Jurado, MsC

    Universitat Politècnica de Catalunya

    PRINCIPAL INVESTIGATOR

  • Marc Argilés Sans, PhD

    Universitat Politècnica de Catalunya

    STUDY DIRECTOR

  • Lluïsa Quevedo i Junyent, PhD

    Universitat Politècnica de Catalunya

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2020

First Posted

March 19, 2020

Study Start

September 16, 2021

Primary Completion

March 19, 2022

Study Completion

May 20, 2022

Last Updated

December 23, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)