New Pediatric Patching Method to Improve Compliance

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.

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