An interventional study of Pinch Patch/ flat Patch in Amblyopia and Strabismus, sponsored by Baylor College of Medicine. Recruiting at 1 site in United States. Open to participants aged Up to 7 Years. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment
This project will assess whether there is a significant difference in compliance with patching in amblyopic patients whose parents are instructed to pinch the superior and inferior edges of the patch before applying (in order to improve comfort) versus patients whose parents are instructed to place the patch evenly around the orbit.
Patients will present to the pediatric ophthalmology clinic at Texas Children's Hospital. If during the course of their standard care visit it is determined by their pediatric ophthalmologist or optometrist that patching is indicated and that the patient meets eligibility criteria for the study, the eye doctor will explain to the patient's parents the need for patching according to the standard protocol and will then mention to them the study being conducted. If they are interested, an investigator will explain the study, allow patients and parents to ask questions, and will then seek written informed consent. Upon consent, a patient will be assigned an ID code that will be written on their signed consent form. Consenting parents will then be randomized into either the control group (taught to apply the patch using the standard method) or the study group ( taught to apply the patch using our modified technique). The standard technique refers to applying the patch evenly and flatly around the orbit, and the modified technique refers to pinching the middle of the superior and inferior edges of the patch before applying so that the patch is convex and the center is raised above the eye in an attempt to improve patient comfort. All patients will be provided with one box of sample patches. In order to mask parents in both groups, these patches will all have a small incision of 3 millimeters on the lateral edges so that parents will be uncertain if they are assigned to the control or study group. An incision of this size will not significantly alter the function of the patch in any way. Patients will have equal odds of being assigned to either the control or study group using a random number generator. Parents will not be told whether the method they are being taught is the standard or modified method, and their eye doctor will not be told whether or not the parents decided to enroll in the study. After using one full box of patches or after one month, whichever comes first, parents will complete a questionnaire about their compliance with the prescribed patching regimen and any difficulties they may have had in patching their child. We will use the Amblyopia Treatment Index Patching Questionnaire designed by the Pediatric Eye Disease Investigator Group, with the addition of several questions related to patients' comfort while patching. Patients will be instructed to return for standard follow-up care as determined by their eye doctor.
189 studies on the registry are indexed under Amblyopia; 41 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 137 interventional studies indexed under Amblyopia.
Browse Amblyopia studies →Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 110 are open to participants now.
Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.
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Exclusion Criteria:
Patients assigned to the Control Arm will be taught to apply their patches using the standard technique -- applying the patch evenly and flatly around the orbit.
Device: Pinch Patch/ flat Patch
Patients assigned to the Pinched Patch Arm will be taught to apply their patches after pinching the middle of the superior and inferior edges of the patch so that the patch is convex and the center is raised above the eye.
Device: Pinch Patch/ flat Patch
Survey Responses
Time frame: baseline
Started Jun 2014 (actual). Primary completion is estimated for Feb 2024, 116 months after the start.
Of 58 non-industry interventional studies with no phase under Amblyopia, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 72. This study's planned 116 months is above that.
Counting every sponsor, half of 71 studies reached it within 33 months; a quarter within 17 and three quarters within 47.
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