Recruiting

Pediatric Patching Method

Sponsor:

Baylor College of Medicine

Code:

NCT02236351

Conditions

Amblyopia

Strabismus

Eligibility Criteria

Sex: All

Age: 0 - 7

Healthy Volunteers: Not accepted

Interventions

Pinch Patch/ flat Patch

Study Details

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.

Conditions

Amblyopia

Strabismus

Study ID

NCT02236351

Start date

Jun, 2014

Status verified date

Jun, 2023

Completion date

May, 2024

Anticipated

Primary completion date

Feb, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 7

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Pinch Patch/ flat Patch

Primary outcome measure

  • Survey Responses [ Time Frame: baseline ]

Central Contacts and Locations

Locations

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Irene T Tung, MD

832-822-3000irene.tung@bcm.edu

Gihan Romany

832-822-3222Giha.Romany@bcm.edu

Principal Investigator:

Michael A Puente, MS

More Information

Sponsor

Baylor College of Medicine

Last update posted

Jun 22, 2023

Last verified

Jun, 2023

Keywords

  • patching
  • pediatric ophthalmology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2023-06-22.