Skip to main content
OpenTrials
Completed

NCT Number: NCT04315649

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

This study evaluates the effect of 3D movie viewing on stereopsis recovery in anisometropic and / or strabismus amblyopia and the satisfaction with the intervention.

Completed

Looking for future studies?

Notify Me

Key information

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laura Asensio Jurado

Barcelona, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3D movie viewing

Other

3D movie viewing

Primary outcomes

  1. Change from baseline Stereopsis, immediately after intervention and at 3 months studying the effect of viewing a 3D movie on visual function.

    Time frame: Baseline, immediately after intervention and 3 months

    Stereopsis (ST in logMAR) will be evaluated by a TNO test.

  2. 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.

    Time frame: Baseline, immediately after intervention and 3 months

    Latent o manifest deviation will be evaluated at 6 m and will be measured by prisms.

  3. 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.

    Time frame: Baseline, immediately after intervention and 3 months

    Latent o manifest deviation will be evaluated at 40cm and will be measured by prisms.

Secondary outcomes

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

    Time frame: Immediately after intervention

    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.

Sponsors and collaborators

Lead sponsor

Universitat Politècnica de Catalunya

Other

Collaborators

  • Hospital Mutua de Terrassa

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 19, 2020
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.