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

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ClinicalTrials.gov Identifier: NCT04315649
Recruitment Status : Not yet recruiting
First Posted : March 19, 2020
Last Update Posted : November 6, 2020
Sponsor:
Collaborator:
Hospital Mutua de Terrassa
Information provided by (Responsible Party):
Universitat Politècnica de Catalunya

Tracking Information
First Submitted Date  ICMJE March 16, 2020
First Posted Date  ICMJE March 19, 2020
Last Update Posted Date November 6, 2020
Estimated Study Start Date  ICMJE May 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2020)
  • Change from baseline Stereopsis (ST with StereoTAB) at 2 weeks and 3 months studying the effect of viewing a 3D movie in the visual function. [ Time Frame: Baseline, 2 weeks and 3 months ]
    Stereopsis (ST in logMAR) will be evaluated by a Multiple Random Points test through an Ipad. The app is StereoTAB and uses anaglyphic glasses. The measures will be performed at 50 cm.
  • Change from baseline Stereopsis (ST with Randot Dot Test) at 2 weeks and 3 months studying the effect of viewing a 3D movie in the visual function. [ Time Frame: Baseline, 2 weeks and 3 months ]
    Stereopsis (ST in logMAR) will be evaluated by a Randot Dot Test. The measures will be performed at 40 cm.
  • Change from baseline latent or manifest deviation at 2 weeks and 3 months studying the effect of viewing a 3D movie in the visual function. [ Time Frame: Baseline, 2 weeks and 3 months ]
    Latent o manifest deviation will be evaluated in the two distances (40 cm and 6 m) and will be measured by prisms.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2020)
Satisfaction assessed by an ordinal questionnaire designed based on the Treatment Satisfaction Questionnaire for Medication (TSQM). [ Time Frame: 2 weeks ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of 3D Movie Viewing on Stereopsis in Strabismus and / or Anisometropic Amblyops
Official Title  ICMJE Effect of 3D Movie Viewing on Stereopsis in Strabismus and / or Anisometropic Amblyops
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Amblyopia
  • Anisometropic Amblyopia
  • Strabismic Amblyopia
Intervention  ICMJE Other: 3D movie viewing
3D movie viewing
Study Arms  ICMJE Experimental: 3D movie
3D movie viewing
Intervention: Other: 3D movie viewing
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 18, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laura Asensio Jurado, MsC 0034636760450 asensiojlaura@gmail.com
Contact: Marc Argilés Sans, PhD 00346636818571 marcargiles@gmail.com
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04315649
Other Study ID Numbers  ICMJE PhDLAJE2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Universitat Politècnica de Catalunya
Study Sponsor  ICMJE Universitat Politècnica de Catalunya
Collaborators  ICMJE Hospital Mutua de Terrassa
Investigators  ICMJE
Principal Investigator: Laura Asensio Jurado, MsC Universitat Politècnica de Catalunya
Study Director: Marc Argilés Sans, PhD Universitat Politècnica de Catalunya
Study Director: Lluïsa Quevedo i Junyent, PhD Universitat Politècnica de Catalunya
PRS Account Universitat Politècnica de Catalunya
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP