Access to EyeGlasses for School-aged Children

NCT05588362 | Unknown DMC

• 1 other identifier: IRB-P00040587
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myopia; Amblyopia; Hyperopia; Refractive Errors

Outcome Measures

Primary Outcomes (19)

• 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

Study Arms (2)

Fitz Frames 3-D Printed Glasses

EXPERIMENTAL

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

Traditional Glasses Procurement Group

NO INTERVENTION

(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.

Interventions

Fitz Frames 3-D Printed Glasses OTHER

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).

Fitz Frames 3-D Printed Glasses

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• strabismus
• developmental or learning delay
• other ocular pathology

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Fitz Frames, Inc.: collaborator

MeSH Terms

Conditions

Myopia; Amblyopia; Hyperopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators responsible for administering questionnaires and collecting visual outcomes will be masked to the treatment group of the participant. Both the research assistant and participant will be unmasked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Optometrist

Model Details: Prospective randomized control study

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 20, 2022
• Study Start: February 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share