AmblyopiaNCT04315649
Effect of 3D Movie Viewing on Stereopsis in Strabismus and / or Anisometropic Amblyops
A study testing 3D movie viewing in people with Amblyopia and Anisometropic Amblyopia, run by Universitat Politècnica de Catalunya at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Amblyopia, Anisometropic Amblyopia, Strabismic Amblyopia
- What is being tested?
- 3D movie viewing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 16 Sep 2021to 20 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Ongoing amblyopia treatment;
- Non-comitant and/or large constant strabismus (>10 prism diopters)
- Any ocular pathological condition or nystagmus.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the effect of 3D movie viewing on stereopsis recovery in anisometropic and / or strabismus amblyopia and the satisfaction with the intervention.
Read the 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.
- Conditions
- Amblyopia, Anisometropic Amblyopia, Strabismic Amblyopia
- Being tested
- 3D movie viewing
- Keywords
- 3D movies, Amblyopia treatment
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D movie viewingOther
3D movie viewing
| Study group | Role | What they receive |
|---|---|---|
| 3D movie | Experimental | 3D movie viewing Receives: Other: 3D movie viewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Stereopsis, immediately after intervention and at 3 months studying the effect of viewing a 3D movie on visual function.
Stereopsis (ST in logMAR) will be evaluated by a TNO test.
Measured: Baseline, immediately after intervention and 3 months
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.
Latent o manifest deviation will be evaluated at 6 m and will be measured by prisms.
Measured: Baseline, immediately after intervention and 3 months
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.
Latent o manifest deviation will be evaluated at 40cm and will be measured by prisms.
Measured: Baseline, immediately after intervention and 3 months
Secondary outcomes (1)
Satisfaction assessed by an ordinal questionnaire designed based on the Treatment Satisfaction Questionnaire for Medication (TSQM).
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.
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start16 Sep 2021
- Primary completion19 Mar 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Politècnica de Catalunya
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Mutua de Terrassa
- Responsible party
- Sponsor
- Investigators
- Laura Asensio Jurado, MsC, Principal investigator, Universitat Politècnica de CatalunyaMarc Argilés Sans, PhD, Study director, Universitat Politècnica de CatalunyaLluïsa Quevedo i Junyent, PhD, Study director, Universitat Politècnica de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315649
- Sponsor's protocol ID
- PhDLAJE2
- Status last verified
- Dec 2022
- First submitted
- 16 Mar 2020
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bridgeman B. Restoring adult stereopsis: a vision researcher's personal experience. Optom Vis Sci. 2014 Jun;91(6):e135-9. doi: 10.1097/OPX.0000000000000272.
PubMed 24811849Levi DM, Knill DC, Bavelier D. Stereopsis and amblyopia: A mini-review. Vision Res. 2015 Sep;114:17-30. doi: 10.1016/j.visres.2015.01.002. Epub 2015 Jan 29.
PubMed 25637854Li RW, Tran KD, Bui JK, Antonucci MM, Ngo CV, Levi DM. Improving Adult Amblyopic Vision with Stereoscopic 3-Dimensional Video Games. Ophthalmology. 2018 Oct;125(10):1660-1662. doi: 10.1016/j.ophtha.2018.04.025. Epub 2018 May 18. No abstract available.
PubMed 29779684Birch EE, Jost RM, De La Cruz A, Kelly KR, Beauchamp CL, Dao L, Stager D Jr, Leffler JN. Binocular amblyopia treatment with contrast-rebalanced movies. J AAPOS. 2019 Jun;23(3):160.e1-160.e5. doi: 10.1016/j.jaapos.2019.02.007. Epub 2019 May 16.
PubMed 31103562Bossi M, Tailor VK, Anderson EJ, Bex PJ, Greenwood JA, Dahlmann-Noor A, Dakin SC. Binocular Therapy for Childhood Amblyopia Improves Vision Without Breaking Interocular Suppression. Invest Ophthalmol Vis Sci. 2017 Jun 1;58(7):3031-3043. doi: 10.1167/iovs.16-20913.
PubMed 28614556
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 3D Movie Viewing on Stereopsis in Strabismus and / or Anisometropic Amblyops
- ClinicalTrials.gov ID
- NCT04315649
- Acronym / sponsor ID
- PhDLAJE2
- Conditions
- Amblyopia, Anisometropic Amblyopia, Strabismic Amblyopia
- Keywords
- 3D movies, Amblyopia treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universitat Politècnica de CatalunyaUniversity, hospital or other
- Collaborators
- Hospital Mutua de Terrassa
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 19 Mar 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D movie | Experimental | Other: 3D movie viewing3D movie viewing |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Ongoing amblyopia treatment;
- Non-comitant and/or large constant strabismus (>10 prism diopters)
- Any ocular pathological condition or nystagmus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D movie viewing3D movie viewing | Other | 3D movie |
Primary outcome
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.
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.
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.
1 secondary outcome
Satisfaction assessed by an ordinal questionnaire designed based on the Treatment Satisfaction Questionnaire for Medication (TSQM).
Time frame: Immediately after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Background: PubMed 24811849Bridgeman B. Restoring adult stereopsis: a vision researcher's personal experience. Optom Vis Sci. 2014 Jun;91(6):e135-9. doi: 10.1097/OPX.0000000000000272.
- Background: PubMed 25637854Levi DM, Knill DC, Bavelier D. Stereopsis and amblyopia: A mini-review. Vision Res. 2015 Sep;114:17-30. doi: 10.1016/j.visres.2015.01.002. Epub 2015 Jan 29.
- Background: PubMed 29779684Li RW, Tran KD, Bui JK, Antonucci MM, Ngo CV, Levi DM. Improving Adult Amblyopic Vision with Stereoscopic 3-Dimensional Video Games. Ophthalmology. 2018 Oct;125(10):1660-1662. doi: 10.1016/j.ophtha.2018.04.025. Epub 2018 May 18. No abstract available.
- Background: PubMed 31103562Birch EE, Jost RM, De La Cruz A, Kelly KR, Beauchamp CL, Dao L, Stager D Jr, Leffler JN. Binocular amblyopia treatment with contrast-rebalanced movies. J AAPOS. 2019 Jun;23(3):160.e1-160.e5. doi: 10.1016/j.jaapos.2019.02.007. Epub 2019 May 16.
- Background: PubMed 28614556Bossi M, Tailor VK, Anderson EJ, Bex PJ, Greenwood JA, Dahlmann-Noor A, Dakin SC. Binocular Therapy for Childhood Amblyopia Improves Vision Without Breaking Interocular Suppression. Invest Ophthalmol Vis Sci. 2017 Jun 1;58(7):3031-3043. doi: 10.1167/iovs.16-20913.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Asensio Jurado, MsC principal investigator
Universitat Politècnica de Catalunya
Marc Argilés Sans, PhD study director
Universitat Politècnica de Catalunya
Lluïsa Quevedo i Junyent, PhD study director
Universitat Politècnica de Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D movie viewing in people with Amblyopia and Anisometropic Amblyopia, run by Universitat Politècnica de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04315649, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.