AmblyopiaNCT03825107
Dichoptic Video Treatment for Amblyopia
A study testing patching and Dichoptic videos in people with Amblyopia, run by Retina Foundation of the Southwest at 1 site in United States.
Trial summary
1. To determine whether watching contrast-rebalanced dichoptic videos is effective in improving visual acuity and reducing interocular suppression in amblyopic children 2. To compare the amount of visual acuity improvement achieved with the videos to tha amount achieved with patching (standard treatment for amblyopia) Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- patching and Dichoptic videos
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2019to 31 Aug 2021
- 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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 3 to 7 years old
- Amblyopic eye visual acuity 20/32-20/125
- Fellow eye visual acuity 20/16-25
- Interocular visual acuity difference of at least 2 lines
- Anisometropia or corrected strabsimus (<5pd)
- in glasses at least 8 weeks or no change in visual acuity over two visits
- no prior binocular treatment
- must be able to see full video screen
Who cannot join
- prematurity of 8 weeks or more
- coexisting ocular or systemic disease
- developmental delay
- poor ocular alignment (>=5 pd)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dichoptic Video Treatment for Amblyopia in Children Age 3-7 Years
- To determine whether watching contrast-rebalanced dichoptic videos is effective in improving visual acuity and reducing interocular suppression in amblyopic children
- To compare the amount of visual acuity improvement achieved with the videos to tha amount achieved with patching (standard treatment for amblyopia)
Read the detailed description
Contrast-rebalanced binocular iPad tablet games (with fellow eye contrast reduced) have been shown to be an effective treatment for amblyopia. However, the games can be challenging for some of the youngest children and boring for some of the older children with amblyopia. To provide additional treatment options using the same contrast-rebalancing approach, we have processed animated videos to allow dichoptic viewing, with full contrast for the amblyopic eye and reduced contrast for the fellow eye. Children will be randomly assigned to watch dichoptic videos (experimental treatment) or patch 2 hours/day every day(standard-of-care amblyopia treatment) for 2 weeks. At the 2-week primary outcome visit, children in the patching group will cross over to the videos and return for a secondary outcome visit at 4 weeks. Families will have the option to continue with the vdeos for up to 8 weeks.
- Conditions
- Amblyopia
- Being tested
- patching, Dichoptic videos
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patchingOther
Also called occlusion therapy
covering the fellow eye with an eyepatch to force use of the amblyopic eye
Dichoptic videosOther
watching contrast-rebalanced dichoptic videos to allow the two eyes to work together
| Study group | Role | What they receive |
|---|---|---|
| Patching | Active comparator | 2 hours per day 7 days per week patching of the fellow eye Receives: Other: patching |
| Dichoptic Videos | Experimental | watching 6 dichoptic videos during each 2 week period Receives: Other: Dichoptic videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual acuity of the amblyopic eye
HOTV (preferred) or picture chart
Measured: Baseline vs 2 weeks
Secondary outcomes (3)
Change in visual acuity of the amblyopic eye
HOTV (preferred) or picture charts
Measured: Baseline vs 4 weeks, 6 weeks, and 8 weeks
Change in Stereoacuity
Randot Preschool Stereoacuity test
Measured: Baseline vs 2, 4, 6, 8 weeks
Change in Contrast Balance Index
Dichoptic Letter chart
Measured: Baseline vs 2, 4, 6, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start31 Jan 2019
- Primary completion6 Jul 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel for primary outcome; crossover for longterm effectiveness
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Retina Foundation of the Southwest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eileen Birch, Retina Foundation of the Southwest
- Investigators
- Eileen E Birch, PhD, Principal investigator, Retina Foundation of the Southwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825107
- Sponsor's protocol ID
- Dichoptic Video for Amblyopia
- Status last verified
- Jan 2025
- First submitted
- 29 Jan 2019
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jost RM, Kelly KR, Birch EE. Risk of recurrence after cessation of dichoptic, binocular treatment of amblyopia. J AAPOS. 2023 Oct;27(5):298-300. doi: 10.1016/j.jaapos.2023.06.009. Epub 2023 Aug 23.
PubMed 37619861Jost RM, Hudgins LA, Dao LM, Stager DR Jr, Luu B, Beauchamp CL, Hunter JS, Giridhar P, Wang YZ, Birch EE. Randomized clinical trial of streaming dichoptic movies versus patching for treatment of amblyopia in children aged 3 to 7 years. Sci Rep. 2022 Mar 9;12(1):4157. doi: 10.1038/s41598-022-08010-9.
PubMed 35264692
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dichoptic Video Treatment for Amblyopia in Children Age 3-7 Years
- ClinicalTrials.gov ID
- NCT03825107
- Acronym / sponsor ID
- Dichoptic Video for Amblyopia
- Conditions
- Amblyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Retina Foundation of the SouthwestUniversity, hospital or other
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 6 Jul 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 31 Jan 2019 (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.
- To determine whether watching contrast-rebalanced dichoptic videos is effective in improving visual acuity and reducing interocular suppression in amblyopic children
- To compare the amount of visual acuity improvement achieved with the videos to tha amount achieved with patching (standard treatment for amblyopia)
Detailed description
Contrast-rebalanced binocular iPad tablet games (with fellow eye contrast reduced) have been shown to be an effective treatment for amblyopia. However, the games can be challenging for some of the youngest children and boring for some of the older children with amblyopia. To provide additional treatment options using the same contrast-rebalancing approach, we have processed animated videos to allow dichoptic viewing, with full contrast for the amblyopic eye and reduced contrast for the fellow eye. Children will be randomly assigned to watch dichoptic videos (experimental treatment) or patch 2 hours/day every day(standard-of-care amblyopia treatment) for 2 weeks. At the 2-week primary outcome visit, children in the patching group will cross over to the videos and return for a secondary outcome visit at 4 weeks. Families will have the option to continue with the vdeos for up to 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel for primary outcome; crossover for longterm effectiveness
| Arm | Type | Receives |
|---|---|---|
| Patching | Active comparator | Other: patching2 hours per day 7 days per week patching of the fellow eye |
| Dichoptic Videos | Experimental | Other: Dichoptic videoswatching 6 dichoptic videos during each 2 week period |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 3 to 7 years old
- Amblyopic eye visual acuity 20/32-20/125
- Fellow eye visual acuity 20/16-25
- Interocular visual acuity difference of at least 2 lines
- Anisometropia or corrected strabsimus (<5pd)
Key exclusion criteria (4 listed)
- prematurity of 8 weeks or more
- coexisting ocular or systemic disease
- developmental delay
- poor ocular alignment (>=5 pd)
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 |
|---|---|---|
| patchingAlso: occlusion therapycovering the fellow eye with an eyepatch to force use of the amblyopic eye | Other | Patching |
| Dichoptic videoswatching contrast-rebalanced dichoptic videos to allow the two eyes to work together | Other | Dichoptic Videos |
Primary outcome
Change in visual acuity of the amblyopic eye
Time frame: Baseline vs 2 weeks
HOTV (preferred) or picture chart
3 secondary outcomes
Change in visual acuity of the amblyopic eye
Time frame: Baseline vs 4 weeks, 6 weeks, and 8 weeks
Change in Stereoacuity
Time frame: Baseline vs 2, 4, 6, 8 weeks
Change in Contrast Balance Index
Time frame: Baseline vs 2, 4, 6, 8 weeks
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 24 Jan 2025.
- Derived from this study: PubMed 37619861Jost RM, Kelly KR, Birch EE. Risk of recurrence after cessation of dichoptic, binocular treatment of amblyopia. J AAPOS. 2023 Oct;27(5):298-300. doi: 10.1016/j.jaapos.2023.06.009. Epub 2023 Aug 23.
- Derived from this study: PubMed 35264692Jost RM, Hudgins LA, Dao LM, Stager DR Jr, Luu B, Beauchamp CL, Hunter JS, Giridhar P, Wang YZ, Birch EE. Randomized clinical trial of streaming dichoptic movies versus patching for treatment of amblyopia in children aged 3 to 7 years. Sci Rep. 2022 Mar 9;12(1):4157. doi: 10.1038/s41598-022-08010-9.
- Individual participant dataSharing planned: No
Related trials for Amblyopia
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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.
Eileen E Birch, PhD principal investigator
Retina Foundation of the Southwest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patching and Dichoptic videos in people with Amblyopia, run by Retina Foundation of the Southwest at 1 site in United States.
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 8 inclusion and 4 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 24 Jan 2025. 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 United States. 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 in visual acuity of the amblyopic eye (time frame: Baseline vs 2 weeks). 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 NCT03825107, which also lists 2 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 24 Jan 2025.