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

Sponsor
Universitat Politècnica de Catalunya (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04315649
Collaborator
Hospital Mutua de Terrassa (Other)
40
1
1
5
8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 3D movie viewing
N/A

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 Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Oct 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 3D movie

3D movie viewing

Other: 3D movie viewing
3D movie viewing

Outcome Measures

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. [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. [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. [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). [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.

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Laura Asensio Jurado Barcelona Spain

Sponsors and Collaborators

  • Universitat Politècnica de Catalunya
  • Hospital Mutua de Terrassa

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Universitat Politècnica de Catalunya
ClinicalTrials.gov Identifier:
NCT04315649
Other Study ID Numbers:
  • PhDLAJE2
First Posted:
Mar 19, 2020
Last Update Posted:
Nov 6, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 6, 2020