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Terminated
NCT05588362
Access to EyeGlasses for School-aged Children
Conditions: Myopia, Amblyopia, Hyperopia, Refractive Errors
Sex: All
Ages: 5 Years – 17 Years
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Boston Children's Hospital
Location: Boston Children's Hospital Boston Massachusetts
Summary
Uncorrected refractive error is a leading cause of visual impairment in children and can impact vision, quality of life, and academic performance. Despite Boston Children's Hospital serving patients from a wide range of socioeconomic backgrounds, there are health disparities in access to eyeglasses as a consequence of patients' health insurance. The investigators will examine whether the use of an in-clinic app for 3-D printed glasses reduces disparities in access to eyeglasses for our patients on Medicaid. The intervention will address social determinants of health and improve pediatric health outcomes namely, how and when children having publicly funded health insurance receive eyeglasses. The short-term objectives are (1) to compare the time to receive glasses between publicly funded MassHealth eyeglasses and an in-clinic order of 3D printed glasses (2) to evaluate compliance with glasses wear in these two groups, and (3) to evaluate visual function and quality-of-life outcomes in these two groups. This prospective randomized control study will evaluate barriers to accessing eyeglasses in school-aged children. The investigators will recruit children enrolled in MassHealth and randomize them into two cohorts: (1) the control group will receive MassHealth glasses as per standard of care, through an optical shop of their choosing, or (2) the intervention group will use an app for immediately ordering glasses (paid for by the study) in clinic following their appointment. The investigators will evaluate the time needed to receive eyeglasses, compliance with glasses wear, quality of life, and visual outcomes between the cohorts at one-, three-, and six-month intervals. Through this project, the investigators will not only evaluate, quantify, and bring awareness to disparities in our patient population, but will also look toward finding a solution through the use of a novel application that addresses many of the barriers faced by patients insured through Medicaid.
Eligibility Criteria
Inclusion Criteria:
* Masshealth insurance
* first-time glasses wearers
* receive a diagnosis of refractive amblyopia, myopia, hyperopia and/or astigmatism requiring spectacle correction for optimal vision at distance and near.
* Glasses must be recommended for full time wear by the attending optometrist or ophthalmologist
Exclusion Criteria:
* strabismus
* developmental or learning delay
* other ocular pathology
Source: ClinicalTrials.gov (NCT05588362). StuddyBuddy aggregates publicly available trial information.