AmblyopiaNCT03288948
Binocular Amblyopia Treatment
A study testing Binocular games for treatment of amblyopia in people with Amblyopia, run by Retina Foundation of the Southwest at 1 site in United States.
Trial summary
To evaluate the effectiveness of enhanced binocular amblyopia treatments in achieving a more complete and stable recovery. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Binocular games for treatment of amblyopia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2017to 31 Dec 2026
- 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age 4-10 y
- male and female
- strabismic, anisometropic, or combined mechanism amblyopia
- amblyopic eye best-corrected visual acuity 0.3-0.8 logMAR
- fellow eye best-corrected visual acuity ≤0.1 logMAR
- interocular visual acuity difference ≥0.3 logMAR
Show all 11Show fewer
- wearing glasses (if needed) for 8 weeks or no change visual acuity with glasses at 2 visits
- 4 weeks apart.
- child's ophthalmologist and family must be willing to forgo patching treatment during the 12-week study period
- parent's informed consent
- child must demonstrate understanding and ability to play binocular games
Who cannot join
- prematurity ≥8 weeks
- coexisting ocular or systemic disease
- developmental delay
- strabismus >5pd
- any binocular amblyopia treatment in the past 3 months
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 of the Southwest
Dallas, Texas, 75231
Pediatric Laboratory, 2143633911 ext. 113
Eileen E Birch, PhD
About this study
To evaluate the effectiveness of enhanced binocular amblyopia treatments in achieving a more complete and stable recovery.
Read the detailed description
To date, all studies of contrast-rebalanced binocular amblyopia treatment games used the same 10% per day contrast-increment that was designed for short-term intervention studies lasting 1-4 weeks; i.e., after 18 days of successful game play, both eyes viewed 100% contrast (no contrast-rebalancing).This study will investigate two alternative protocols designed to extend the game treatment period beyond 4 weeks to allow for more complete recovery of visual acuity. The new protocols will be compared with the original 10% contrast-increment game protocol in an 8-week 3-arm RCT to determine whether one or both of the new protocols is more effective than the current 10% increment.
Based on pilot data, we expect about 40% of amblyopic children to achieve normal visual acuity in 8 weeks. In an effort to also promote recovery of binocular vision, children who attain ≤0.4 logMAR at 8 weeks will be enrolled in stereoacuity training at the 8-week visit for the next 4 weeks. Children with residual amblyopia (BCVA >0.4 logMAR) at the 8-week visit will be provided with dichoptic movies for additional amblyopia treatment for another 4 weeks.
- Conditions
- Amblyopia
- Being tested
- Binocular games for treatment of amblyopia
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binocular games for treatment of amblyopiaOther
playing binocular games on a tablet platform 1 hour per day 5 days per week with reduced contrast for the fellow eye and high contrast for the amblyopic eye
| Study group | Role | What they receive |
|---|---|---|
| Standard Contrast Increment | Active comparator | Not described Receives: Other: Binocular games for treatment of amblyopia |
| Reduced Contrast Increment | Experimental | Not described Receives: Other: Binocular games for treatment of amblyopia |
| No Contrast Increment | Experimental | Not described Receives: Other: Binocular games for treatment of amblyopia |
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
ATS-HOTV for age 4-6.9 years or E-ETDRS for age 7-10.9 years
Measured: baseline vs 8 weeks
Secondary outcomes (3)
Change in visual acuity of the amblyopic eye
ATS-HOTV for age 4-6.9 years or E-ETDRS for age 7-10.9 years
Measured: baseline vs 2, 4, 6, and 12 weeks
Change in stereoacuity
Randot Preschool Stereoacuity Test
Measured: baseline vs 2, 4, 6, 8, 12 weeks
Change in suppression
Dichoptic Letter Chart
Measured: baseline vs 2, 4, 6, 8, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start31 Aug 2017
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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
- Masking
- None (open label)
- Enrolment
- 120 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
- NCT03288948
- Sponsor's protocol ID
- 062010-105
- Other IDs
- R01EY022313
- Status last verified
- Feb 2026
- First submitted
- 18 Sep 2017
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we will only share aggregated data
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, Kelly KR, Hunter JS, Stager DR Jr, Luu B, Leffler JN, Dao L, Beauchamp CL, Birch EE. A randomized clinical trial of contrast increment protocols for binocular amblyopia treatment. J AAPOS. 2020 Oct;24(5):282.e1-282.e7. doi: 10.1016/j.jaapos.2020.06.009. Epub 2020 Oct 9.
PubMed 33045374
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Binocular Amblyopia Treatment
- ClinicalTrials.gov ID
- NCT03288948
- Acronym / sponsor ID
- 062010-105
- Conditions
- Amblyopia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Retina Foundation of the SouthwestUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Sep 2017 (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 evaluate the effectiveness of enhanced binocular amblyopia treatments in achieving a more complete and stable recovery.
Detailed description
To date, all studies of contrast-rebalanced binocular amblyopia treatment games used the same 10% per day contrast-increment that was designed for short-term intervention studies lasting 1-4 weeks; i.e., after 18 days of successful game play, both eyes viewed 100% contrast (no contrast-rebalancing).This study will investigate two alternative protocols designed to extend the game treatment period beyond 4 weeks to allow for more complete recovery of visual acuity. The new protocols will be compared with the original 10% contrast-increment game protocol in an 8-week 3-arm RCT to determine whether one or both of the new protocols is more effective than the current 10% increment.
Based on pilot data, we expect about 40% of amblyopic children to achieve normal visual acuity in 8 weeks. In an effort to also promote recovery of binocular vision, children who attain ≤0.4 logMAR at 8 weeks will be enrolled in stereoacuity training at the 8-week visit for the next 4 weeks. Children with residual amblyopia (BCVA >0.4 logMAR) at the 8-week visit will be provided with dichoptic movies for additional amblyopia treatment for another 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Contrast Increment | Active comparator | Other: Binocular games for treatment of amblyopia |
| Reduced Contrast Increment | Experimental | Other: Binocular games for treatment of amblyopia |
| No Contrast Increment | Experimental | Other: Binocular games for treatment of amblyopia |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- age 4-10 y
- male and female
- strabismic, anisometropic, or combined mechanism amblyopia
- amblyopic eye best-corrected visual acuity 0.3-0.8 logMAR
- fellow eye best-corrected visual acuity ≤0.1 logMAR
Key exclusion criteria (5 listed)
- prematurity ≥8 weeks
- coexisting ocular or systemic disease
- developmental delay
- strabismus >5pd
- any binocular amblyopia treatment in the past 3 months
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 |
|---|---|---|
| Binocular games for treatment of amblyopiaplaying binocular games on a tablet platform 1 hour per day 5 days per week with reduced contrast for the fellow eye and high contrast for the amblyopic eye | Other | No Contrast Increment, Reduced Contrast Increment, Standard Contrast Increment |
Primary outcome
Change in visual acuity of the amblyopic eye
Time frame: baseline vs 8 weeks
ATS-HOTV for age 4-6.9 years or E-ETDRS for age 7-10.9 years
3 secondary outcomes
Change in visual acuity of the amblyopic eye
Time frame: baseline vs 2, 4, 6, and 12 weeks
Change in stereoacuity
Time frame: baseline vs 2, 4, 6, 8, 12 weeks
Change in suppression
Time frame: baseline vs 2, 4, 6, 8, 12 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 23 Feb 2026.
- 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 33045374Jost RM, Kelly KR, Hunter JS, Stager DR Jr, Luu B, Leffler JN, Dao L, Beauchamp CL, Birch EE. A randomized clinical trial of contrast increment protocols for binocular amblyopia treatment. J AAPOS. 2020 Oct;24(5):282.e1-282.e7. doi: 10.1016/j.jaapos.2020.06.009. Epub 2020 Oct 9.
- Individual participant dataSharing planned: No. we will only share aggregated data
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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 Binocular games for treatment of amblyopia 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 11 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 23 Feb 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 Reed Jost, MS (2143633911 ext. 113, reedjost@retinafoundation.org), or a site near the patient. 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 8 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 NCT03288948, 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 23 Feb 2026.