RECRUITING

Patch-free Occlusion Therapy

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the study is to determine whether a patch-free occlusion therapy leads to better visual outcomes in young children with amblyopia than standard-of-care occlusion therapy with an adhesive patch and whether this is associated with better adherence to the treatment.

Official Title

Patch-free Occlusion Therapy

Quick Facts

Study Start:2023-06-12

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05440448

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.

Ages Eligible for Study:3 Years to 10 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* 3-10 years (3-7 primary cohort) * male and female * strabismic, anisometropic, or combined mechanism amblyopia (visual acuity: 0.3-0.8 logMAR) * interocular visual acuity difference ≥0.3 logMAR * wearing glasses (if needed) for a minimum of 8 weeks with no change in visual acuity at 2 visits ≥4 weeks apart * child's ophthalmologist and family willing to forgo standard patching treatment during the study	* Prematurity ≥8 wk * coexisting ocular or systemic disease * developmental delay * myopia \> -3.00D

Inclusion Criteria

Exclusion Criteria

* 3-10 years (3-7 primary cohort)
* male and female
* strabismic, anisometropic, or combined mechanism amblyopia (visual acuity: 0.3-0.8 logMAR)
* interocular visual acuity difference ≥0.3 logMAR
* wearing glasses (if needed) for a minimum of 8 weeks with no change in visual acuity at 2 visits ≥4 weeks apart
* child's ophthalmologist and family willing to forgo standard patching treatment during the study

* Prematurity ≥8 wk
* coexisting ocular or systemic disease
* developmental delay
* myopia \> -3.00D

Contacts and Locations

Study Contact

Eileen E Birch, PhD

CONTACT

2143633911

ebirch@retinafoundation.org

Reed M Jost, MS

CONTACT

2143633911

reedjost@retinafoundation.org

Study Locations (Sites)

Retina Foundation

Dallas, Texas, 75231

United States

Collaborators and Investigators

Sponsor: Retina Foundation of the Southwest

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 Registration Dates

Study Start Date2023-06-12

Study Completion Date2027-12

Study Record Updates

Study Start Date2023-06-12

Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

Amblyopia