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New Pediatric Patching Method to Improve Compliance

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ClinicalTrials.gov Identifier: NCT02236351
Recruitment Status : Unknown
Verified September 2014 by Michael A. Puente, Jr., Texas Children's Hospital.
Recruitment status was:  Recruiting
First Posted : September 10, 2014
Last Update Posted : September 10, 2014
Sponsor:
Information provided by (Responsible Party):
Michael A. Puente, Jr., Texas Children's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Amblyopia Strabismus Device: Pinched Patch Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : June 2014
Estimated Primary Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

Arm Intervention/treatment
Placebo Comparator: Control
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.
Experimental: Pinched 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: Pinched Patch



Primary Outcome Measures :
  1. Survey Responses [ Time Frame: baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients prescribed an eye patch by a pediatric ophthalmologist or optometrist to treat either strabismus, anisometropia, or deprivation amblyopia
  • Patients aged from birth up to and including 7 years old

Exclusion Criteria:

  • Known skin reaction to patch or bandage adhesive

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236351


Locations
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United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Michael A Puente, MS    504-251-5747    puente@bcm.edu   
Principal Investigator: Michael A Puente, MS         
Sub-Investigator: David K Coats, MD         
Sub-Investigator: Jane C Edmond, MD         
Sub-Investigator: Evelyn A Paysse, MD         
Sub-Investigator: Mohamed A Hussein, MD         
Sub-Investigator: Kimberly G Yen, MD         
Sub-Investigator: Honey Herce, MD         
Sub-Investigator: Amit R Bhatt, MD         
Sub-Investigator: Mary K Kelinske, OD         
Sub-Investigator: Lingkun Kong, MD, PhD         
Sub-Investigator: Candice Gardemal         
Sub-Investigator: Miranda Freyre         
Sub-Investigator: Christine Romero         
Sub-Investigator: Aries Rojas         
Sponsors and Collaborators
Texas Children's Hospital

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Responsible Party: Michael A. Puente, Jr., Medical Student Researcher, Texas Children's Hospital
ClinicalTrials.gov Identifier: NCT02236351     History of Changes
Other Study ID Numbers: H-34627
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: September 10, 2014
Last Verified: September 2014
Keywords provided by Michael A. Puente, Jr., Texas Children's Hospital:
patching
pediatric ophthalmology
Additional relevant MeSH terms:
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Amblyopia
Strabismus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Ocular Motility Disorders
Cranial Nerve Diseases