New Pediatric Patching Method to Improve Compliance

NCT ID: NCT02236351

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2024-05-31

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.

Conditions

Amblyopia; Strabismus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Pinch Patch/ flat Patch

Intervention Type: DEVICE

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.

Group Type: EXPERIMENTAL

Pinch Patch/ flat Patch

Intervention Type: DEVICE

Interventions

Pinch Patch/ flat Patch

Intervention Type: DEVICE

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

• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Irene Tintin Tung

Assistant Professor, TCH Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Texas Children's Hospital

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Irene T Tung, MD

Role: primary

irene.tung@bcm.edu

832-822-3000

Gihan Romany

Role: backup

Giha.Romany@bcm.edu

832-822-3222

Other Identifiers

H-34627

Identifier Type: -

Identifier Source: org_study_id