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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

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.

Condition or disease Intervention/treatment Phase
Amblyopia Anisometropic Amblyopia Strabismic Amblyopia Other: 3D movie viewing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of 3D Movie Viewing on Stereopsis in Strabismus and / or Anisometropic Amblyops
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

Arm Intervention/treatment
Experimental: 3D movie
3D movie viewing
Other: 3D movie viewing
3D movie viewing




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04315649


Contacts
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Contact: Laura Asensio Jurado, MsC 0034636760450 asensiojlaura@gmail.com
Contact: Marc Argilés Sans, PhD 00346636818571 marcargiles@gmail.com

Locations
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Spain
Laura Asensio Jurado
Barcelona, Spain
Sponsors and Collaborators
Universitat Politècnica de Catalunya
Hospital Mutua de Terrassa
Investigators
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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
Publications:
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Responsible Party: Universitat Politècnica de Catalunya
ClinicalTrials.gov Identifier: NCT04315649    
Other Study ID Numbers: PhDLAJE2
First Posted: March 19, 2020    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitat Politècnica de Catalunya:
3D movies
Amblyopia treatment
Additional relevant MeSH terms:
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Amblyopia
Strabismus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Ocular Motility Disorders
Cranial Nerve Diseases