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| Name | Class |
|---|---|
| Fera Pharmaceuticals, LLC | UNKNOWN |
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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:
Participants will be asked to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atropine + Echothiophate Combination Therapy | Other | Single-group interventional Arm - Atropine + Echothiophate Combination Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity (BCVA) | 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) | Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Interocular visual acuity difference | Difference in BCVA between the amblyopic and fellow eye, measured in logMAR. | Baseline, 4 weeks, 8 weeks, 12 weeks, and 14 weeks. |
| Change in stereoacuity | Change in log arcseconds of stereoacuity assessed with the Randot Preschool Stereoacuity Test. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Crystal McAfee | Contact | 405-271-6307 | Crystal-McAfee@dmei.org |
| Name | Affiliation | Role |
|---|---|---|
| Tammy Yanovitch, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dean McGee Eye Institute | Oklahoma City | Oklahoma | 73104 | United States |
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| ID | Term |
|---|---|
| D000550 | Amblyopia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014786 | Vision Disorders |
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| ID | Term |
|---|---|
| D004456 | Echothiophate Iodide |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D063086 | Organothiophosphates |
| D010755 | Organophosphates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| 4 weeks, 8 weeks, 12 weeks, 14 weeks |
| Refractive error changes | Changes in spherical equivalent refraction from baseline in the amblyopic eye, measured in diopters. | 4 weeks, 8 weeks, 12 weeks (after completion of echothiophate treatment), 14 weeks (after two-week wash-out period). |
| Ocular alignment | This measure evaluates the presence and magnitude of ocular deviation measured in prism diopters, assessed at distance and near fixation | Baseline, 4 weeks, 8 weeks, 12 weeks, and 14 weeks. |
| Contrast sensitivity | The ability of the amblyopic eye to distinguish an object from its background under varying levels of contrast, assessed using a standardized contrast sensitivity chart (e.g., Pelli-Robson) and reported in log contrast sensitivity units. | 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) | The PedEyeQ is an instrument specific to pediatric eye conditions designed to evaluate health-related quality of life in children with eye conditions. The assessment values are Rasch calibrated and scaled to score from 0 (worst) to 100 (best) | Baseline, 4 weeks, 8 weeks, 12 weeks, 14 weeks |
| Treatment adherence | This measure assess the proportion of prescribed treatments completed as directed over the study period, including frequency and consistency of administration | From baseline to the end of treatment at 14 weeks. |
| OCT-A foveal avascular zone (FAZ) area changes | Examine difference/change in OCT-A foveal avascular zone (FAZ) area between amblyopic and non-amblyopic eye with treatment. Units are in square millimeters (mm^2) | 4 weeks, 8 weeks, 12 weeks, 14 weeks |
| OCT-A foveal avascular zone (FAZ) perimeter changes | Examine changes in OCT-A foveal avascular zone (perimeter) changes between the amblyopic and non-amblyopic eye with treatment measured in millimeters (mm). | 4 weeks, 8 weeks, 12 weeks, 14 weeks |
| OCT-A foveal avascular zone (FAZ) circularity index changes | Examine changes in foveal avascular zone (FAZ) circularity index between the amblyopic and non-amblyopic eye with treatment. Circularity is measured by utilizing the FAZ area and perimeter by multiplying the area by 4 pi and dividing by the squared perimeter. This measurement is unitless. | 4 weeks, 8 weeks, 12 weeks, 14 weeks |
| OCT-A vessel density changes | Examine the differences in OCT-A between amblyopic and non-amblyopic eye with treatment. Measured as the proportion of the area occupied by vasculature. | 4 weeks, 8 weeks, 12 weeks, 14 weeks |
| OCT-A vessel diameter index (VDI) changes | Examine the changes in the VDI between amblyopic and non-amblyopic eye with treatment. Measured as the average vessel caliber in micrometers (µm). | 4 weeks, 8 weeks, 12 weeks, 14 weeks |
| OCT-A perfusion density (PD) changes | Changes in PD between the amblyopic and non-amblyopic eye with treatment. Measured as the total area of perfused vasculature per unit area (%) | 4 weeks, 8 weeks, 12 weeks, 14 weeks |
| OCT-A retinal thickness changes | Examine changes in retinal thickness between amblyopic and non-amblyopic eye with treatment. Measured in microns. | 4 weeks, 8 weeks, 12 weeks, 14 weeks |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009946 |
| Organothiophosphorus Compounds |
| D013457 | Sulfur Compounds |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |