Clinical trial NCT05588362: Access to EyeGlasses for School-aged Children
Official title: Access to EyeGlasses for School-aged Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myopia
Amblyopia
Hyperopia
Refractive Errors
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Fitz Frames, Inc.
First posted: 2022-10-20
Enrollment: 72
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized control study
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Compliance
timeFrame: Six months
measure: Quality of Life Questionnaire
timeFrame: Baseline, will be collected at enrollment visit
measure: Distance visual acuity
timeFrame: Baseline, will be collected at enrollment visit
measure: Distance visual acuity
timeFrame: 0-3 Months, will be collected at 3 month visit
measure: Distance visual acuity
timeFrame: 3-6 Months, will be collected at 6 month visit
measure: Stereoacuity
timeFrame: Baseline, will be collected at enrollment visit
measure: Stereoacuity
timeFrame: 0-3 Months, will be collected at 3 month visit
measure: Stereoacuity
timeFrame: 3-6 Months, will be collected at 6 month visit
measure: Ocular alignment
timeFrame: Baseline, will be collected at enrollment visit
measure: Ocular alignment
timeFrame: 0-3 Months, will be collected at 3 month visit
measure: Ocular alignment
timeFrame: 3-6 Months, will be collected at 6 month visit
measure: Near point of convergence
timeFrame: Baseline, will be collected at enrollment visit
measure: Near point of convergence
timeFrame: 0-3 Months, will be collected at 3 month visit
measure: Near point of convergence
timeFrame: 3-6 Months, will be collected at 6 month visit
measure: Near visual acuity
timeFrame: Baseline, will be collected at enrollment visit
measure: Near visual acuity
timeFrame: 0-3 Months, will be collected at 3 month visit
measure: Near visual acuity
timeFrame: 3-6 Months, will be collected at 6 month visit
measure: Quality of Life Questionnaire- PedEyeQ
timeFrame: 0-3 Months, will be collected at 3 month visit
measure: Quality of Life Questionnaire- PedEyeQ
timeFrame: 3-6 Months, will be collected at 6 month visit
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: