Effect of 3D Movie Viewing on Stereopsis in Strabismus and / or Anisometropic Amblyops
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04315649|
Recruitment Status : Not yet recruiting
First Posted : March 19, 2020
Last Update Posted : November 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Amblyopia Anisometropic Amblyopia Strabismic Amblyopia||Other: 3D movie viewing||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: 3D movie
3D movie viewing
Other: 3D movie viewing
3D movie viewing
- 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.
- 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.
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
|Contact: Laura Asensio Jurado, MsCfirstname.lastname@example.org|
|Contact: Marc Argilés Sans, PhDemail@example.com|
|Laura Asensio Jurado|
|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|