New Pediatric Patching Method to Improve Compliance

June 19, 2023 updated by: Irene Tintin Tung, Baylor College of Medicine
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital
        • Contact:
        • Contact:
        • 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:
          • Candice Gardemal
        • Sub-Investigator:
          • Miranda Freyre
        • Sub-Investigator:
          • Christine Romero
        • Sub-Investigator:
          • Kelsie B Morrison, OD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.
Device: Pinch Patch/ flat Patch
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: Pinch Patch/ flat Patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survey Responses
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

September 8, 2014

First Submitted That Met QC Criteria

September 9, 2014

First Posted (Estimated)

September 10, 2014

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 19, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-34627

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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