Access to EyeGlasses for School-aged Children

Myopia Clinical Trial

— ATEG  

Official title:

Access to EyeGlasses for School-aged Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05588362
• Other study ID #: IRB-P00040587
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: January 2023
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: December 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Amblyopia
• Hyperopia
• Myopia
• Refractive Errors

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children's Hospital	Fitz Frames, Inc.

Outcome

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