Evaluation of Echothiophate in Pediatric Patients With Refractory Amblyopia (NCT07554131) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Evaluation of Echothiophate in Pediatric Patients With Refractory Amblyopia
United States20 participantsStarted 2026-06
Plain-language summary
The goal of this clinical trial is to see if a medicine called echothiophate iodide (Phospholine Iodide) can help treat children with refractory amblyopia. Amblyopia (also called lazy eye) is when one eye doesn't see as well as it should because the brain isn't using that eye correctly. Refractory amblyopia means a lazy eye that's very difficult to treat and it doesn't improve even after using common treatments, such as putting atropine eye drops in the stronger eye to encourage use of the weaker eye.
The main questions this study aims to answer are:
* Can adding echothiophate iodide eye drops help children who stopped improving with atropine alone start making progress again?
* Does using atropine and echothiophate iodide eye drops together work better for older children and adolescents who typically do not respond well to atropine alone?
* Besides improving eyesight, can echothiophate iodide eye drops also help with things like depth perception, seeing in crowded spaces, or noticing motion
Participants will be asked to:
* Participate in the study for a total of 14 weeks
* Attend four clinic visits
* Use atropine drops in the stronger eye nightly for a total 12 weeks
* Use of echothiophate iodide eye drops in the weaker eye in addition to atropine use in the stronger eye, if vision does not improve after 4 weeks of use of atropine alone in the stronger eye
* Upload weekly photos of the eyes
* Have a slit lamp exam performed at each visit
* Have Best Corrected Visual Acuity (BCVA) eye measurements taken at each visit.
* Have Optical Coherence Tomography Angiography (OCTA) images taken at at each visit.
Who can participate
Age range
3 Years – 17 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:
* 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 Criteria:
* 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 su…
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.