Evaluation of Echothiophate in Pediatric Patients With Refractory Amblyopia

Conditions

• Refractory Amblyopia

Eligibility Criteria

Sex

ALL

Age

3 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Echothiophate Iodide 0.125% Ophthalmic Solution — DRUG
  Participants will receive echothiophate iodide eye drops in addition to standard atropine therapy to assess whether the combination improves visual function in refractory amblyopia.

Study Details

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.

Key Dates

Start date

Jun 30, 2026

Status verified

Apr 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Other: Atropine + Echothiophate Combination Therapy
  Single-group interventional Arm - Atropine + Echothiophate Combination Therapy

Primary Outcome Measure

Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks. ]

Central Contacts

• Crystal McAfee
  405-271-6307
  [email protected]

Locations (1)

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