Access to EyeGlasses for School-aged Children

Study Overview
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Brief Summary
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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.

Official Title
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Access to EyeGlasses for School-aged Children

Conditions
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Myopia, Amblyopia, Hyperopia, Refractive Errors

Intervention / Treatment
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* Other: Fitz Frames 3-D Printed Glasses


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized control study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fitz Frames 3-D Printed Glasses<br>The intervention group will order glasses directly in the office following their exam and consent using an iPad with the help of the research assistant. The iPad will be e-connected to a 3D printed glasses manufacturer (Fitz Frames) through their application, allowing the child (with assistance from the doctor or research assistant) to take various measurements in real time. Sixteen different measurements will be taken including interpupillary distance, face length, face width, and temple measures. The child will be able to choose frame style and order it directly from the manufacturer immediately following the exam. Glasses will be shipped directly to the patient's home (shipping address will be input to the app by the family). | Other: Fitz Frames 3-D Printed Glasses<br>* The intervention group will order glasses directly in the office following their exam and consent using an iPad with the help of the research assistant. The iPad will be e-connected to a 3D printed glasses manufacturer (Fitz Frames) through their application, allowing the child (with assistance from the doctor or research assistant) to take various measurements in real time. Sixteen different measurements will be taken including interpupillary distance, face length, face width, and temple measures. The child will be able to choose frame style and order it directly from the manufacturer immediately following the exam. Glasses will be shipped directly to the patient's home (shipping address will be input to the app by the family).<br>|
| No Intervention: Traditional Glasses Procurement Group<br>(1) The control group will receive standard of care in which a prescription for glasses will be dispensed as a paper copy prescribed by the examiner before randomization. The research assistant will use a script (attached) that instructs families how to procure glasses traditionally through Masshealth. The participant/family will be instructed to bring the paper prescription to an optical shop that carries MassHealth frames. A printout of local optical shops that carry MassHealth frames will be provided to the patient. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance | Glasses compliance will be assessed with self-reported calendar | Six months | 
| Quality of Life Questionnaire | Quality of life measures using the PedEyeQ | Baseline, will be collected at enrollment visit | 
| Distance visual acuity | Linear Snellen optotypes (age >6) or HOTV matching with crowding bars (age <6) | Baseline, will be collected at enrollment visit | 
| Distance visual acuity | Linear Snellen optotypes (age >6) or HOTV matching with crowding bars (age <6) | 0-3 Months, will be collected at 3 month visit | 
| Distance visual acuity | Linear Snellen optotypes (age >6) or HOTV matching with crowding bars (age <6) | 3-6 Months, will be collected at 6 month visit | 
| Stereoacuity | Stereo Fly test | Baseline, will be collected at enrollment visit | 
| Stereoacuity | Stereo Fly test | 0-3 Months, will be collected at 3 month visit | 
| Stereoacuity | Stereo Fly test | 3-6 Months, will be collected at 6 month visit | 
| Ocular alignment | Alternative prism cover test at distance and at near | Baseline, will be collected at enrollment visit | 
| Ocular alignment | Alternative prism cover test at distance and at near | 0-3 Months, will be collected at 3 month visit | 
| Ocular alignment | Alternative prism cover test at distance and at near | 3-6 Months, will be collected at 6 month visit | 
| Near point of convergence | Near point of convergence (break point and recovery) will be measured using an accommodative target | Baseline, will be collected at enrollment visit | 
| Near point of convergence | Near point of convergence (break point and recovery) will be measured using an accommodative target | 0-3 Months, will be collected at 3 month visit | 
| Near point of convergence | Near point of convergence (break point and recovery) will be measured using an accommodative target | 3-6 Months, will be collected at 6 month visit | 
| Near visual acuity | Near visual acuity will be measured at 40 cm using the Rosenbaum card | Baseline, will be collected at enrollment visit | 
| Near visual acuity | Near visual acuity will be measured at 40 cm using the Rosenbaum card | 0-3 Months, will be collected at 3 month visit | 
| Near visual acuity | Near visual acuity will be measured at 40 cm using the Rosenbaum card | 3-6 Months, will be collected at 6 month visit | 
| Quality of Life Questionnaire- PedEyeQ | Quality of life measures using the PedEyeQ | 0-3 Months, will be collected at 3 month visit | 
| Quality of Life Questionnaire- PedEyeQ | Quality of life measures using the PedEyeQ | 3-6 Months, will be collected at 6 month visit |