AmblyopiaNCT05440448
Patch-free Occlusion Therapy
A study testing Patch-free occlusion therapy and Adhesive patch in people with Amblyopia, run by Retina Foundation of the Southwest at 1 site in United States.
Trial summary
The purpose of the study is to determine whether a patch-free occlusion therapy 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 the treatment. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Patch-free occlusion therapy and Adhesive patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2024to 30 Jun 2028
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 3-12 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
- 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, 75231
Reed M Jost, MS, 214-363-3911 ext. 113, reedjost@retinafoundation.org
ebirch@retinafoundation.org
About this study
The purpose of the study is to determine whether a patch-free occlusion therapy 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 the treatment.
Read the detailed description
This is a single-site randomized clinical trial to compare patch-free occlusion therapy with standard-of-care occlusion therapy with an adhesive patch in young children with amblyopia. 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 12 weeks (primary outcome). Adherence will be objectively monitored with a Theramon sensor. Vision will be re-assessed at 6 weeks and all tests will be repeated at 12 weeks. The patch-free occlusion group will have an option to continue the patch-free occlusion for and additional 6 or 12 weeks (24 weeks total). The standard-of-care occlusion group will be offered the opportunity to use the patch-free treatment at the 12 week visit through 24 weeks. Children who choose to remain in the study beyond the 12 week primary outcome visit will have vision reassessed at 18 and 24 weeks.
The primary analysis will be a comparison of improvement in amblyopic eye visual acuity (baseline-12 weeks) between the patch-free occlusion group and the standard-of-care patching group. Secondary analyses will include comparisons adherence to each treatment, comparison of the proportion of children in each group with visual acuity ≤0.1 logMAR (recovered) at 6 and 12 weeks visit and 95% CIs (at 6 and 12 weeks), 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 12 and 24 weeks for the patch-free group (12, 18, and 24 weeks means and 95% CIs).
- Conditions
- Amblyopia
- Being tested
- Patch-free occlusion therapy, Adhesive patch
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patch-free occlusion therapyDevice
Use of filters in glasses to provide occlusion therapy
Adhesive patchDevice
Standard-of-care occlusion therapy with an adhesive patch
| Study group | Role | What they receive |
|---|---|---|
| Patch-free occlusion therapy | Experimental | Not described Receives: Device: Patch-free occlusion therapy |
| Standard-of-care patching with an adhesive patch | Active comparator | Not described Receives: Device: Adhesive patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in amblyopic eye visual acuity measured with a logMAR visual acuity chart
change in logMAR relative to baseline
Measured: 12 weeks
Secondary outcomes (9)
Change in amblyopic eye visual acuity measured with a logMAR visual acuity chart
change in logMAR relative to baseline
Measured: 6,18, and 24 weeks
Adherence to patching or viewing videos with glasses measured with a sensor
cumulative hours of treatment with the patch or glasses used to watch videos objectively monitored with the skin temperature sensitive Theramon sensor
Measured: 6 and 12 weeks
Proportion of children who have recovered
Proportion of children who attain amblyopic eye visual acuity of 0.1 logMAR or better
Measured: 6 and 12 weeks
Change in extent of suppression assessed with W4 test
changes in log deg measure with W4 test
Measured: 6 and 12 weeks
change in stereoacuity assessed with the Randot Preschool Stereoacuity Test
change in log arcsec
Measured: 6 and 12 weeks
Change in motor skills assessed with the Movement Assessment Battery for Children-2
change in Movement Assessment Battery for Children-2 (MABC-2) standard scores relative to baseline (normed and scaled 0-19 for worst to best, with 10=average, 5-6 = "at risk", and <5 = "significant impairment")
Measured: 12 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: 12 weeks
Improvement in quality of life assesses 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: 12 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 and 12 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 start22 Apr 2024
- Primary completion31 Jan 2028 (estimated)
- Study completion30 Jun 2028 (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
- 68 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
- NCT05440448
- Sponsor's protocol ID
- RFSW113A
- Other IDs
- R01EY022313
- Status last verified
- Jan 2026
- First submitted
- 17 Jun 2022
- Last updated
- 7 Jan 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 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patch-free Occlusion Therapy
- ClinicalTrials.gov ID
- NCT05440448
- Acronym / sponsor ID
- RFSW113A
- Conditions
- Amblyopia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Retina Foundation of the SouthwestUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 30 Jun 2028 (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 the study is to determine whether a patch-free occlusion therapy 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 the treatment.
Detailed description
This is a single-site randomized clinical trial to compare patch-free occlusion therapy with standard-of-care occlusion therapy with an adhesive patch in young children with amblyopia. 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 12 weeks (primary outcome). Adherence will be objectively monitored with a Theramon sensor. Vision will be re-assessed at 6 weeks and all tests will be repeated at 12 weeks. The patch-free occlusion group will have an option to continue the patch-free occlusion for and additional 6 or 12 weeks (24 weeks total). The standard-of-care occlusion group will be offered the opportunity to use the patch-free treatment at the 12 week visit through 24 weeks. Children who choose to remain in the study beyond the 12 week primary outcome visit will have vision reassessed at 18 and 24 weeks.
The primary analysis will be a comparison of improvement in amblyopic eye visual acuity (baseline-12 weeks) between the patch-free occlusion group and the standard-of-care patching group. Secondary analyses will include comparisons adherence to each treatment, comparison of the proportion of children in each group with visual acuity ≤0.1 logMAR (recovered) at 6 and 12 weeks visit and 95% CIs (at 6 and 12 weeks), 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 12 and 24 weeks for the patch-free group (12, 18, and 24 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 |
|---|---|---|
| Patch-free occlusion therapy | Experimental | Device: Patch-free occlusion therapy |
| Standard-of-care patching with an adhesive patch | Active comparator | Device: Adhesive patch |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 3-12 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 (4 listed)
- Prematurity ≥8 wk
- coexisting ocular or systemic disease
- developmental delay
- 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 |
|---|---|---|
| Patch-free occlusion therapyUse of filters in glasses to provide occlusion therapy | Device | Patch-free occlusion therapy |
| Adhesive patchStandard-of-care occlusion therapy with an adhesive patch | Device | Standard-of-care patching with an adhesive patch |
Primary outcome
Change in amblyopic eye visual acuity measured with a logMAR visual acuity chart
Time frame: 12 weeks
change in logMAR relative to baseline
9 secondary outcomes
Change in amblyopic eye visual acuity measured with a logMAR visual acuity chart
Time frame: 6,18, and 24 weeks
Adherence to patching or viewing videos with glasses measured with a sensor
Time frame: 6 and 12 weeks
Proportion of children who have recovered
Time frame: 6 and 12 weeks
Change in extent of suppression assessed with W4 test
Time frame: 6 and 12 weeks
change in stereoacuity assessed with the Randot Preschool Stereoacuity Test
Time frame: 6 and 12 weeks
Change in motor skills assessed with the Movement Assessment Battery for Children-2
Time frame: 12 weeks
Change in self-perception assessed with the Pictorial Scale of Perceived Competence and Social Acceptance for Young Children
Time frame: 12 weeks
Improvement in quality of life assesses with the Pediatric Eye Questionnaire
Time frame: 12 weeks
Change in depth of suppression assessed with the contrast balance index
Time frame: 6 and 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 7 Jan 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 Patch-free occlusion therapy and Adhesive patch 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 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: looking for participants now, as of the sponsor's last update on 7 Jan 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 measured with a logMAR visual acuity chart (time frame: 12 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 Jan 2026.