AmblyopiaNCT05439200
Video Treatment for Amblyopia
A study testing Asynchronous 3D movies and Patching in people with Amblyopia, run by Retina Foundation of the Southwest at 1 site in United States.
Trial summary
The purpose of this study is to determine whether viewing asynchronous movies leads to better visual outcomes in young children with amblyopia than standard-of-care occlusion therapy with an adhesive patch and whether this is associated with better adherence to treatment. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Asynchronous 3D movies and Patching
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- aged 3-7 years
- male and female
- strabismic, anisometropic, or combined mechanism amblyopia (visual acuity 0.3-0.8 logMAR)
- interocular visual acuity difference ≥0.3 logMAR
- wearing glasses (if needed) for a minimum of 8 weeks with no change in visual acuity at 2 visits ≥4 weeks apart
- child's ophthalmologist and family willing to forgo standard patching treatment during the study
Who cannot join
- prematurity ≥8 wk
- coexisting ocular or systemic disease
- developmental delay
- strabismus >5 pd
- myopia > -3.00D
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Retina Foundation
Dallas, Texas, 75241
Reed M Jost, MS, 214-363-3911 ext. 113, reedjiost@retinafoundation.org
ebirch@retinafoundation.org
About this study
The purpose of this study is to determine whether viewing asynchronous movies leads to better visual outcomes in young children with amblyopia than standard-of-care occlusion therapy with an adhesive patch and whether this is associated with better adherence to treatment.
Read the detailed description
This is a single-site randomized clinical trial to compare treatment of amblyopia by viewing asynchronous movies to standard-of-care occlusion therapy with an adhesive patch. Participants will be referred from local pediatric ophthalmologists. Following informed consent, children will complete baseline testing to confirm eligibility and provide pre-treatment measurements of visual acuity, suppression, stereoacuity, motor skills, self-perception, and quality of life. Eligible children will then be randomly allocated to either patch-free occlusion therapy or standard-of-care occlusion therapy with an adhesive patch.
Children will participate in their assigned occlusion therapy at home for 6 weeks (primary outcome). Adherence will be objectively monitored. Vision will be re-assessed at 2 weeks and all tests will be repeated at 6 weeks. The asynchronous movie group will have an option to continue for and additional 2 or 4 weeks (10 weeks total). The standard-of-care occlusion group will be offered the opportunity to use the movie treatment at the 6 week visit through 10 weeks. Children who choose to remain in the study beyond the 6 week primary outcome visit will have vision reassessed at 8 and 10 weeks.
The primary analysis will be a comparison of improvement in amblyopic eye visual acuity (baseline-6 weeks) between the movie group and the standard-of-care patching group. Secondary analyses will include comparisons of adherence to each treatment, comparison of the proportion of children in each group with visual acuity ≤0.1 logMAR (recovered) at 6 weeks and 95% CIs, comparisons of changes in extent of suppression, depth of suppression, stereoacuity, motor skills standard scores, self-perception scores, and PedEyeQ domain scores. Associations among hours of treatment, changes in visual acuity, suppression, and stereoacuity, will be explored and modeled for dose-response relationships. In exploratory analyses, we will examine whether there are additional improvements in visual acuity, suppression, or stereoacuity between 6 and 10 weeks for the movie group (8 and 10 weeks means and 95% CIs).
- Conditions
- Amblyopia
- Being tested
- Asynchronous 3D movies, Patching
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asynchronous 3D moviesDevice
3D movies streamed at home for viewing on a handheld lenticular 3D screen
PatchingDevice
Adhesive patch to cover the fellow eye
| Study group | Role | What they receive |
|---|---|---|
| Asynchronous movies | Experimental | Asynchronous 3D movies Receives: Device: Asynchronous 3D movies |
| Standard-of-care patching with an adhesive patch | Active comparator | Standard-of-care patching with an adhesive patch Receives: Device: Patching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in amblyopic eye visual acuity using a logMAR chart
change in amblyopic eye logMAR visual acuity relative to baseline
Measured: 6 weeks
Secondary outcomes (9)
Change in amblyopic eye visual acuity using a logMAR chart
change in amblyopic eye logMAR visual acuity relative to baseline at 2, 8, and 10 weeks
Measured: 2, 8, and 10 weeks
Change in extent suppression assessed with the W4 test
change in log deg assessed with the W4 test relative to baseline
Measured: 6 weeks
Change in stereoacuity assessed with the Randot Preschool Stereoacuity Test
change in log arcsec in stereoacuity assessed with the Randot Preschool Stereoacuity Test
Measured: 6 weeks
Change in motor skills assessed with the Movement Assessment Battery for Children -2
change in standard scores obtained with the Movement Assessment Battery for Children -2 (MABC-2; (normed and scaled 0-19, with 10 as an average score, 5-6 as "at risk", and <5 as "significant impairment")
Measured: 6 weeks
Change in self perception assessed with the Pictorial Scale of Perceived Competence and Social Acceptance for Young Children
change in domain scores of the Pictorial Scale of Perceived Competence and Social Acceptance for Young Children (standard scores scaled to range from 0 to 100 for worst to best)
Measured: 6 weeks
Change in quality of life assessed with the Pediatric Eye Questionnaire
change in domain scores of the Pediatric Eye Questionnaire (PedEyeQ; Rasch calibrated and scaled to score from 0 to 100 for worst to best)
Measured: 6 weeks
Proportion of children who have recovered
proportion of children who attain amblyopic eye visual acuity of at least 0.1 logMAR
Measured: 2, 6, 8, and 10 weeks
Adherence to patching measured with a sensor and adherence to viewing videos measured with the streaming log data
cumulative hours of treatment with the patch objectively monitored temperature sensitive Theramon sensor or with movie viewing by monitoring the streaming logs
Measured: 2,4, and 6 weeks
Change in depth of suppression assessed with the contrast balance index
change in contrast balance index (ratio of amblyopic eye to fellow eye contrast needed to overcome suppression
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start23 Aug 2023
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Retina Foundation of the Southwest
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, Eileen Birch, Retina Foundation of the Southwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439200
- Sponsor's protocol ID
- RFSW113B
- Other IDs
- R01EY022313
- Status last verified
- Apr 2026
- First submitted
- 17 Jun 2022
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Treatment for Amblyopia
- ClinicalTrials.gov ID
- NCT05439200
- Acronym / sponsor ID
- RFSW113B
- Conditions
- Amblyopia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Retina Foundation of the SouthwestUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Jun 2022 (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.
The purpose of this study is to determine whether viewing asynchronous movies leads to better visual outcomes in young children with amblyopia than standard-of-care occlusion therapy with an adhesive patch and whether this is associated with better adherence to treatment.
Detailed description
This is a single-site randomized clinical trial to compare treatment of amblyopia by viewing asynchronous movies to standard-of-care occlusion therapy with an adhesive patch. Participants will be referred from local pediatric ophthalmologists. Following informed consent, children will complete baseline testing to confirm eligibility and provide pre-treatment measurements of visual acuity, suppression, stereoacuity, motor skills, self-perception, and quality of life. Eligible children will then be randomly allocated to either patch-free occlusion therapy or standard-of-care occlusion therapy with an adhesive patch.
Children will participate in their assigned occlusion therapy at home for 6 weeks (primary outcome). Adherence will be objectively monitored. Vision will be re-assessed at 2 weeks and all tests will be repeated at 6 weeks. The asynchronous movie group will have an option to continue for and additional 2 or 4 weeks (10 weeks total). The standard-of-care occlusion group will be offered the opportunity to use the movie treatment at the 6 week visit through 10 weeks. Children who choose to remain in the study beyond the 6 week primary outcome visit will have vision reassessed at 8 and 10 weeks.
The primary analysis will be a comparison of improvement in amblyopic eye visual acuity (baseline-6 weeks) between the movie group and the standard-of-care patching group. Secondary analyses will include comparisons of adherence to each treatment, comparison of the proportion of children in each group with visual acuity ≤0.1 logMAR (recovered) at 6 weeks and 95% CIs, comparisons of changes in extent of suppression, depth of suppression, stereoacuity, motor skills standard scores, self-perception scores, and PedEyeQ domain scores. Associations among hours of treatment, changes in visual acuity, suppression, and stereoacuity, will be explored and modeled for dose-response relationships. In exploratory analyses, we will examine whether there are additional improvements in visual acuity, suppression, or stereoacuity between 6 and 10 weeks for the movie group (8 and 10 weeks means and 95% CIs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asynchronous movies | Experimental | Device: Asynchronous 3D moviesAsynchronous 3D movies |
| Standard-of-care patching with an adhesive patch | Active comparator | Device: PatchingStandard-of-care patching with an adhesive patch |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- aged 3-7 years
- male and female
- strabismic, anisometropic, or combined mechanism amblyopia (visual acuity 0.3-0.8 logMAR)
- interocular visual acuity difference ≥0.3 logMAR
- wearing glasses (if needed) for a minimum of 8 weeks with no change in visual acuity at 2 visits ≥4 weeks apart
Key exclusion criteria (5 listed)
- prematurity ≥8 wk
- coexisting ocular or systemic disease
- developmental delay
- strabismus >5 pd
- myopia > -3.00D
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 |
|---|---|---|
| Asynchronous 3D movies3D movies streamed at home for viewing on a handheld lenticular 3D screen | Device | Asynchronous movies |
| PatchingAdhesive patch to cover the fellow eye | Device | Standard-of-care patching with an adhesive patch |
Primary outcome
Change in amblyopic eye visual acuity using a logMAR chart
Time frame: 6 weeks
change in amblyopic eye logMAR visual acuity relative to baseline
9 secondary outcomes
Change in amblyopic eye visual acuity using a logMAR chart
Time frame: 2, 8, and 10 weeks
Change in extent suppression assessed with the W4 test
Time frame: 6 weeks
Change in stereoacuity assessed with the Randot Preschool Stereoacuity Test
Time frame: 6 weeks
Change in motor skills assessed with the Movement Assessment Battery for Children -2
Time frame: 6 weeks
Change in self perception assessed with the Pictorial Scale of Perceived Competence and Social Acceptance for Young Children
Time frame: 6 weeks
Change in quality of life assessed with the Pediatric Eye Questionnaire
Time frame: 6 weeks
Proportion of children who have recovered
Time frame: 2, 6, 8, and 10 weeks
Adherence to patching measured with a sensor and adherence to viewing videos measured with the streaming log data
Time frame: 2,4, and 6 weeks
Change in depth of suppression assessed with the contrast balance index
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asynchronous 3D movies and Patching 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 7 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eileen E Birch, PhD (2143633911 ext. 113, ebirch@retinafoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in amblyopic eye visual acuity using a logMAR chart (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2026.