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

Not Applicable

Completed

• Conditions: Amblyopia; Strabismic Amblyopia; Anisometropic Amblyopia
• Interventions: Other: 3D movie viewing

• Registration Number: NCT04315649
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-03-18
• Study First Posted: 2020-03-19
• Study Start: 2021-09-16
• Primary Completion: 2022-03-19
• Study Completion: 2022-05-20
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3D movie	3D movie viewing	3D movie viewing

Primary Outcome Measures

Name	Time	Method
Change from baseline Stereopsis, immediately after intervention and at 3 months studying the effect of viewing a 3D movie on visual function.	Baseline, immediately after intervention and 3 months	Stereopsis (ST in logMAR) will be evaluated by a TNO test.
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.	Baseline, immediately after intervention and 3 months	Latent o manifest deviation will be evaluated at 6 m and will be measured by prisms.
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.	Baseline, immediately after intervention and 3 months	Latent o manifest deviation will be evaluated at 40cm and will be measured by prisms.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Laura Asensio Jurado; 🇪🇸 Barcelona, Spain