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Echothiophate for Refractory Amblyopia in Children

This study is looking into whether adding echothiophate iodide eye drops can help children aged 3 to 17 years old who have refractory amblyopia (a 'lazy eye' that hasn't improved with standard treatments like atropine eye drops). Refractory amblyopia means the lazy eye is very difficult to treat and hasn't gotten better with usual methods. The goal is to see if this combination treatment can improve vision in the weaker eye. We will measure vision at different times over 14 weeks to see if there's an improvement. The study plans to enroll 20 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants.
What's involved
Participants will receive echothiophate iodide eye drops in addition to their current atropine therapy. Vision will be measured at baseline, 4 weeks, 8 weeks, 12 weeks, and 14 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your vision will be measured at baseline, 4 weeks, 8 weeks, 12 weeks, and 14 weeks after starting the treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07554131

Evaluation of Echothiophate in Pediatric Patients With Refractory Amblyopia

Not Yet Recruiting
PHASE2Ages 3–17InterventionalTreatment
University of Oklahoma
~20 participants
Updated 2026-04-28 on ClinicalTrials.gov
What's tested:Echothiophate Iodide 0.125% Ophthalmic Solution

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Best Corrected Visual Acuity (BCVA)
Measured over Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks.

Conditions

Refractory Amblyopia

Explore related trials

Amblyopia

Where it's being run

1 sites across 1 states
Oklahoma1

Study leadership

  • Tammy Yanovitch, MD · PRINCIPAL_INVESTIGATOR · University of Oklahoma

Who to contact

Crystal McAfee
[email protected]
405-271-6307
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Children/adolescents between 3 and \<18 years old with amblyopia who are currently undergoing atropine treatment who are deemed to no longer be improving.
Diagnosis of amblyopia associated with strabismus, anisometropia, or mixed types (as defined by previous PEDIG studies).
Wearing appropriate spectacle correction based on cycloplegic refraction using PEDIG protocol recommendations.
Currently undergoing atropine treatment (either 2x a week or every other day) with visual acuity in the amblyopic eye that has not improved with atropine treatment from participant's previous visit.
Cycloplegic refraction that has been completed within 6 months of enrollment.
Ability to measure visual acuity using standardized testing protocols.
Visual acuity in the amblyopic eye 20/40 to 20/100. Visual acuity in the non-amblyopic eye 20/30 or better with intraocular difference greater than or equal to 2 lines.

Exclusion

Existing ocular conditions likely to interfere with treatment response (e.g., congenital cataract history, corneal opacities/scars, ptosis, retinal diseases).
Neurologic or systemic conditions that impact vision.
Severe developmental delays that might impact treatment adherence and outcome evaluation.
Current use of prisms or bifocals.
Active uveal inflammation or history of angle-closure glaucoma.
Concurrent use of other anticholinesterase medications.
Anticipated surgical procedures during the study period.
Prior surgical interventions for ocular conditions that could interfere with study outcomes.
Myopia with spherical equivalent \>6D.
Any contraindications to the components of the medicine to be used in the study

What this trial measures

  • Best Corrected Visual Acuity (BCVA)Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks.

    Best Corrected Visual Acuity (BCVA) after 8 weeks of echothiophate iodide treatment and after a 2-week washout period (study-certified visual acuity tester masked to the patient's treatment group)