New Pediatric Patching Method to Improve Compliance
Primary Purpose
Amblyopia, Strabismus
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pinch Patch/ flat Patch
Sponsored by
About this trial
This is an interventional treatment trial for Amblyopia focused on measuring patching, pediatric ophthalmology
Eligibility 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
Sites / Locations
- Texas Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
Pinched Patch
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Survey Responses
Secondary Outcome Measures
Full Information
NCT ID
NCT02236351
First Posted
September 8, 2014
Last Updated
June 19, 2023
Sponsor
Baylor College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02236351
Brief Title
New Pediatric Patching Method to Improve Compliance
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2014 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia, Strabismus
Keywords
patching, pediatric ophthalmology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Pinched Patch
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Pinch Patch/ flat Patch
Primary Outcome Measure Information:
Title
Survey Responses
Time Frame
baseline
10. Eligibility
Sex
All
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irene T Tung, MD
Phone
832-822-3000
Email
irene.tung@bcm.edu
First Name & Middle Initial & Last Name & Degree
Gihan Romany
Phone
832-822-3222
Email
Giha.Romany@bcm.edu
First Name & Middle Initial & Last Name & Degree
Michael A Puente, MS
First Name & Middle Initial & Last Name & Degree
David K Coats, MD
First Name & Middle Initial & Last Name & Degree
Jane C Edmond, MD
First Name & Middle Initial & Last Name & Degree
Evelyn A Paysse, MD
First Name & Middle Initial & Last Name & Degree
Mohamed A Hussein, MD
First Name & Middle Initial & Last Name & Degree
Kimberly G Yen, MD
First Name & Middle Initial & Last Name & Degree
Honey Herce, MD
First Name & Middle Initial & Last Name & Degree
Amit R Bhatt, MD
First Name & Middle Initial & Last Name & Degree
Mary K Kelinske, OD
First Name & Middle Initial & Last Name & Degree
Candice Gardemal
First Name & Middle Initial & Last Name & Degree
Miranda Freyre
First Name & Middle Initial & Last Name & Degree
Christine Romero
First Name & Middle Initial & Last Name & Degree
Kelsie B Morrison, OD
12. IPD Sharing Statement
Learn more about this trial
New Pediatric Patching Method to Improve Compliance
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