Access to EyeGlasses for School-aged Children (ATEG)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Refractive Errors; Myopia; Hyperopia; Amblyopia
• Intervention / Treatment: Other: Fitz Frames 3-D Printed Glasses

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fitz Frames 3-D Printed Glasses; 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; 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).
No Intervention: Traditional Glasses Procurement Group; (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?

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

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Fitz Frames, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: October 3, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 20, 2022

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Refractive Errors; Hyperopia; Amblyopia
• Other Study ID Numbers: IRB-P00040587

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No