Bifocal Spectacles vs. Single Vision Spectacles for Esotropia Greater at Near (NCT05527015) | Clinical Trial Compass
WithdrawnPhase 3
Bifocal Spectacles vs. Single Vision Spectacles for Esotropia Greater at Near
Stopped: Concerns over recruitment feasibility
0Started 2025-09
Plain-language 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 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
Who can participate
Age range
3 Years – 9 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
* 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 crite…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants meeting treatment failure at any follow up visit before 36 months