New Pediatric Patching Method to Improve Compliance

NCT02236351 | Unknown

• 1 other identifier: H-34627
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

patching; pediatric ophthalmology

Outcome Measures

Primary Outcomes (1)

• Survey Responses

  baseline

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Pinched Patch

EXPERIMENTAL

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

Interventions

Pinch Patch/ flat Patch DEVICE

Control; Pinched Patch

Eligibility Criteria

• Age: Up to 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Known skin reaction to patch or bandage adhesive

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Amblyopia; Strabismus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ocular Motility Disorders; Cranial Nerve Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, TCH Ophthalmology

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: September 10, 2014
• Study Start: June 1, 2014
• Primary Completion: February 1, 2024
• Study Completion: May 1, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

US (1)