Evaluation of Echothiophate in Pediatric Patients With Refractory Amblyopia

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Best Corrected Visual Acuity (BCVA) [Срок оценки: Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks.]

Вторичные конечные точки (12)

• Interocular visual acuity difference [Срок оценки: Baseline, 4 weeks, 8 weeks, 12 weeks, and 14 weeks.]
• Change in stereoacuity [Срок оценки: 4 weeks, 8 weeks, 12 weeks, 14 weeks]
• Refractive error changes [Срок оценки: 4 weeks, 8 weeks, 12 weeks (after completion of echothiophate treatment), 14 weeks (after two-week wash-out period).]
• Ocular alignment [Срок оценки: Baseline, 4 weeks, 8 weeks, 12 weeks, and 14 weeks.]
• Contrast sensitivity [Срок оценки: Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks]
• Quality of life measures using the Pediatric Eye Disease Investigator Group (PEDIG) Pediatric Eye Questionnaire (PedEyeQ) [Срок оценки: Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks]
• Treatment adherence [Срок оценки: From baseline to the end of treatment at 14 weeks.]
• OCT-A foveal avascular zone (FAZ) area changes [Срок оценки: 4 weeks, 8 weeks, 12 weeks, 14 weeks]
• OCT-A foveal avascular zone (FAZ) perimeter changes [Срок оценки: 4 weeks, 8 weeks, 12 weeks, 14 weeks]
• OCT-A foveal avascular zone (FAZ) circularity index changes [Срок оценки: 4 weeks, 8 weeks, 12 weeks, 14 weeks]
• OCT-A vessel density changes [Срок оценки: 4 weeks, 8 weeks, 12 weeks, 14 weeks]
• OCT-A vessel diameter index (VDI) changes [Срок оценки: 4 weeks, 8 weeks, 12 weeks, 14 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Dean McGee Eye Institute — Oklahoma City

Идентификаторы

NCT: NCT07554131 · 19462

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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