EsotropiaPhase 3ETS3NCT05527015
Bifocal Spectacles vs. Single Vision Spectacles for Esotropia Greater at Near
A Phase 3 study testing Bifocal Spectacles and Single Vision Lenses in people with Esotropia, run by Jaeb Center for Health Research.
Trial summary
Compare the proportion of BFL and SVL participants with treatment failure by 36 months, compare binocular function test scores between the BFL and SVL groups with both groups in BFL at 38 months after randomization (or 2 months after treatment failure), and evaluate treatment failure by 36 months according to baseline… Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Esotropia
- What is being tested?
- Bifocal Spectacles and Single Vision Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Feb 2034
- Phase
- Phase 3
- 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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 3 to <9 years
- Esodeviation meeting all the following criteria is present in refractive correction (if required or worn)
- Constant or intermittent esotropia ≥10∆ measurable by SPCT at near
- Distance esotropia (constant, intermittent), esophoria, or orthophoria, with near esodeviation ≥10∆ larger than distance deviation by PACT
- If constant ET at distance, then must be ≤6∆ by SPCT
- If intermittent ET or esophoric at distance, can be any magnitude at distance (as long as near esodeviation is ≥10∆ larger than distance deviation by PACT)
Show all 20Show fewer
- Cycloplegic refraction within past 3 months (but not on day of exam)
- Wearing spectacles for at least 4 weeks if refractive error is 0.75 D SE or more
- Spectacles (if worn) must meet the following criteria:
- SE refractive error must be corrected within ±0.625 D
- Sphere power must be corrected within ±0.50 D
- Anisometropia must be corrected within ±0.50 D SE
- Cylinder power must be corrected within ±0.50 D
- Cylinder axis must be within ±10 degrees if cylinder power is ≤1.00 D and within ±5 degrees if cylinder power is >1.00 D.
- Best-corrected VA meeting the following criteria:
- Better-seeing eye VA is age-normal (see section 2.2)
- IOD in VA within 0.2 logMAR (although previous amblyopia is allowed)
- Worse-seeing eye VA of 20/63 or better
- Investigator and parent willing to forgo treatment of ET other than assigned randomized treatment for 36 months unless failure criteria are met.
- Investigator willing to prescribe BFL-spectacles only (in both treatment groups) for 2 months after meeting failure criteria (if failed prior to 36 months); otherwise, between 36 and 38 months
Who cannot join
- Previous BFL wear (SVL spectacle wear of any duration is allowed)
- Current or planned contact lens wear over the next 3 years
- Myopic refractive error of more than -6.00 D SE
- Previous strabismus surgery (including Botox injection), intraocular surgery (e.g., laser, anti-VEGF injection, or cataract), extraocular surgery (e.g., scleral buckle), or refractive surgery
- Previous treatment for ET using miotics, VT, or prism within prior 3 months
- Amblyopia treatment other than refractive correction within prior 3 months
Show all 15Show fewer
- Vertical deviation ≥3Δ at distance or near by PACT
- Oculomotor findings consistent with infantile ET (e.g., latent nystagmus, manifest nystagmus, DVD)
- AV pattern: ≥10∆ difference between upgaze and downgaze by PACT at distance
- Paretic or restrictive strabismus
- Constant exotropia at near when tested through the +3.00 D add (intermittent XT and exophoria are allowed)
- Diplopia "more than 2 times per day" over the last week prior to enrollment by parental report. The frequency of diplopia, if any, must be "2 times or less per day" to be eligible.
- Significant developmental delay that would interfere with child's ability to complete testing
- Neurological conditions that could affect ocular motility (e.g., cerebral palsy, Down syndrome)
- Immediate family member (child or sibling) of any site personnel directly affiliated with the study
About this study
Official title: Randomized Trial of Bifocal Spectacles vs. Single Vision Spectacles for Esotropia Greater at Near
Compare the proportion of BFL and SVL participants with treatment failure by 36 months, compare binocular function test scores between the BFL and SVL groups with both groups in BFL at 38 months after randomization (or 2 months after treatment failure), and evaluate treatment failure by 36 months according to baseline factor subgroups of: duration of constant esotropia pre-enrollment, presence of near stereoacuity on the Randot Preschool Stereoacuity test, in-office response of near alignment with +3.00 D lenses, and gradient AC/A ratio
Read the detailed description
Participants will be randomly assigned to treatment with a BFL or SVL spectacle correction for 3 years. Generally, participants will be followed at 3-month intervals for the first year and every 6 months thereafter until the primary outcome visit at 36 months. At each follow-up visit between 3 months and 36 months, ocular alignment and stereoacuity will be assessed to determine if any of the three study-specified failure criteria have been met (worsening of distance esotropia (ET), reduction in near stereoacuity, or frequent diplopia ("more than 2 times per day" over the last week). The primary outcome is failure at or before 36 months.
If a failure criterion is met between 3 to 30 months, participants randomized to SVLs will be prescribed BFLs and those in BFLs will be prescribed continued BFLs. Participants in both groups will return in BFLs 2 months after failure for a Post-failure Secondary Outcome Visit to determine the child's binocular function, after which the child will be released to treatment at investigator discretion. Participants with confirmed failure who complete the Post-failure Secondary Outcome Exam will return for the 12- and 24-month follow-up visits (abbreviated testing) as well as the 38-month Secondary Outcome Visit (they will not return for the 36-month Primary Outcome visit).
If a failure criterion is not met between 3 to 30 months, participants without confirmed failure will complete the 36-month Primary Outcome Visit, After the 36-month visit, SVL group participants will be prescribed BFLs and BFL participants will continue using BFLs.
All participants (i.e., regardless of failure status) will return for a 38-month Secondary Outcome Visit to assess binocular function.
- Conditions
- Esotropia
- Being tested
- Bifocal Spectacles, Single Vision Lenses
- Keywords
- esotropia, bifocal
- Medical subject headings
- Esotropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifocal SpectaclesDevice
Bifocals with a +3.00 Diopter flat top 35
Single Vision LensesDevice
Single vision lens as prescribed by provider
| Study group | Role | What they receive |
|---|---|---|
| Single vision spectacles (SVLs) | Active comparator | Not described Receives: Device: Single Vision Lenses |
| Bifocal spectacles (BFLs) | Experimental | Not described Receives: Device: Bifocal Spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants meeting treatment failure at any follow up visit before 36 months
Failure criteria can be described as
- Distance motor failure: Constant ET ≥15∆ by simultaneous prism and cover test (SPCT) at distance.
- Near stereo failure: Decrease in near stereoacuity on the Randot Preschool Stereotest of 2 or more levels from baseline or from 960" at baseline to nil (criteria not applicable if nil near stereo at baseline)
- Binocular diplopia with a frequency of "more than 2 times per day" over the last week by parental report
- Nonsurgical or surgical treatment for ET, other than the randomized treatment, is started before a failure criterion is met
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study startSep 2025 (estimated)
- Primary completionDec 2033 (estimated)
- Study completionFeb 2034 (estimated)
Why it stopped: Concerns over recruitment feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsotropiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random assignment (1:1) to: * Single vision spectacles (SVLs) * Bifocal spectacles (BFLs): +3.00 D flat-top 35
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI), Pediatric Eye Disease Investigator Group
- Responsible party
- Sponsor
- Investigators
- Michael X Repka, MD, MBA, Study chair, Wilmer Eye Institute, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527015
- Sponsor's protocol ID
- ETS3
- Other IDs
- 2U10EY011751
- Acronym
- ETS3
- Status last verified
- May 2025
- First submitted
- 30 Aug 2022
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Bifocal Spectacles vs. Single Vision Spectacles for Esotropia Greater at Near
- ClinicalTrials.gov ID
- NCT05527015
- Acronym / sponsor ID
- ETS3 / ETS3
- Conditions
- Esotropia
- Keywords
- esotropia, bifocal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Concerns over recruitment feasibility
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI), Pediatric Eye Disease Investigator Group
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2033 (estimated)
- Study completion
- Feb 2034 (estimated)
- First posted
- 2 Sep 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.
Compare the proportion of BFL and SVL participants with treatment failure by 36 months, compare binocular function test scores between the BFL and SVL groups with both groups in BFL at 38 months after randomization (or 2 months after treatment failure), and evaluate treatment failure by 36 months according to baseline factor subgroups of: duration of constant esotropia pre-enrollment, presence of near stereoacuity on the Randot Preschool Stereoacuity test, in-office response of near alignment with +3.00 D lenses, and gradient AC/A ratio
Detailed description
Participants will be randomly assigned to treatment with a BFL or SVL spectacle correction for 3 years. Generally, participants will be followed at 3-month intervals for the first year and every 6 months thereafter until the primary outcome visit at 36 months. At each follow-up visit between 3 months and 36 months, ocular alignment and stereoacuity will be assessed to determine if any of the three study-specified failure criteria have been met (worsening of distance esotropia (ET), reduction in near stereoacuity, or frequent diplopia ("more than 2 times per day" over the last week). The primary outcome is failure at or before 36 months.
If a failure criterion is met between 3 to 30 months, participants randomized to SVLs will be prescribed BFLs and those in BFLs will be prescribed continued BFLs. Participants in both groups will return in BFLs 2 months after failure for a Post-failure Secondary Outcome Visit to determine the child's binocular function, after which the child will be released to treatment at investigator discretion. Participants with confirmed failure who complete the Post-failure Secondary Outcome Exam will return for the 12- and 24-month follow-up visits (abbreviated testing) as well as the 38-month Secondary Outcome Visit (they will not return for the 36-month Primary Outcome visit).
If a failure criterion is not met between 3 to 30 months, participants without confirmed failure will complete the 36-month Primary Outcome Visit, After the 36-month visit, SVL group participants will be prescribed BFLs and BFL participants will continue using BFLs.
All participants (i.e., regardless of failure status) will return for a 38-month Secondary Outcome Visit to assess binocular function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Random assignment (1:1) to: * Single vision spectacles (SVLs) * Bifocal spectacles (BFLs): +3.00 D flat-top 35
| Arm | Type | Receives |
|---|---|---|
| Single vision spectacles (SVLs) | Active comparator | Device: Single Vision Lenses |
| Bifocal spectacles (BFLs) | Experimental | Device: Bifocal Spectacles |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (20 listed)
- Age 3 to <9 years
- Esodeviation meeting all the following criteria is present in refractive correction (if required or worn)
- Cycloplegic refraction within past 3 months (but not on day of exam)
- Wearing spectacles for at least 4 weeks if refractive error is 0.75 D SE or more
- Spectacles (if worn) must meet the following criteria:
Key exclusion criteria (15 listed)
- Previous BFL wear (SVL spectacle wear of any duration is allowed)
- Current or planned contact lens wear over the next 3 years
- Myopic refractive error of more than -6.00 D SE
- Previous strabismus surgery (including Botox injection), intraocular surgery (e.g., laser, anti-VEGF injection, or cataract), extraocular surgery (e.g., scleral buckle), or refractive surgery
- Previous treatment for ET using miotics, VT, or prism within prior 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 |
|---|---|---|
| Bifocal SpectaclesBifocals with a +3.00 Diopter flat top 35 | Device | Bifocal spectacles (BFLs) |
| Single Vision LensesSingle vision lens as prescribed by provider | Device | Single vision spectacles (SVLs) |
Primary outcome
Number of Participants meeting treatment failure at any follow up visit before 36 months
Time frame: 36 months
Failure criteria can be described as 1. Distance motor failure: Constant ET ≥15∆ by simultaneous prism and cover test (SPCT) at distance. 2. Near stereo failure: Decrease in near stereoacuity on the Randot Preschool Stereotest of 2 or more levels from baseline or from 960" at baseline to nil (criteria not applicable if nil near stereo at baseline) 3. Binocular diplopia with a frequency of "more than 2 times per day" over the last week by parental report 4. Nonsurgical or surgical treatment for ET, other than the randomized treatment, is started before a failure criterion is met
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
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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.
Michael X Repka, MD, MBA study chair
Wilmer Eye Institute, Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bifocal Spectacles and Single Vision Lenses in people with Esotropia, run by Jaeb Center for Health Research.
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 20 inclusion and 15 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: withdrawn, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of Participants meeting treatment failure at any follow up visit before 36 months (time frame: 36 months). 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 31 May 2025; AzTrials last refreshed its copy on 2 Nov 2026.