Access to EyeGlasses for School-aged Children (ATEG)

January 9, 2023 updated by: Emily Wiecek, Boston Children's Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Compliance
Time Frame: Six months
Glasses compliance will be assessed with self-reported calendar
Six months
Quality of Life Questionnaire
Time Frame: Baseline, will be collected at enrollment visit
Quality of life measures using the PedEyeQ
Baseline, will be collected at enrollment visit
Distance visual acuity
Time Frame: Baseline, will be collected at enrollment visit
Linear Snellen optotypes (age >6) or HOTV matching with crowding bars (age <6)
Baseline, will be collected at enrollment visit
Distance visual acuity
Time Frame: 0-3 Months, will be collected at 3 month visit
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
Time Frame: 3-6 Months, will be collected at 6 month visit
Linear Snellen optotypes (age >6) or HOTV matching with crowding bars (age <6)
3-6 Months, will be collected at 6 month visit
Stereoacuity
Time Frame: Baseline, will be collected at enrollment visit
Stereo Fly test
Baseline, will be collected at enrollment visit
Stereoacuity
Time Frame: 0-3 Months, will be collected at 3 month visit
Stereo Fly test
0-3 Months, will be collected at 3 month visit
Stereoacuity
Time Frame: 3-6 Months, will be collected at 6 month visit
Stereo Fly test
3-6 Months, will be collected at 6 month visit
Ocular alignment
Time Frame: Baseline, will be collected at enrollment visit
Alternative prism cover test at distance and at near
Baseline, will be collected at enrollment visit
Ocular alignment
Time Frame: 0-3 Months, will be collected at 3 month visit
Alternative prism cover test at distance and at near
0-3 Months, will be collected at 3 month visit
Ocular alignment
Time Frame: 3-6 Months, will be collected at 6 month visit
Alternative prism cover test at distance and at near
3-6 Months, will be collected at 6 month visit
Near point of convergence
Time Frame: Baseline, will be collected at enrollment visit
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
Time Frame: 0-3 Months, will be collected at 3 month visit
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
Time Frame: 3-6 Months, will be collected at 6 month visit
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
Time Frame: Baseline, will be collected at enrollment visit
Near visual acuity will be measured at 40 cm using the Rosenbaum card
Baseline, will be collected at enrollment visit
Near visual acuity
Time Frame: 0-3 Months, will be collected at 3 month visit
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
Time Frame: 3-6 Months, will be collected at 6 month visit
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
Time Frame: 0-3 Months, will be collected at 3 month visit
Quality of life measures using the PedEyeQ
0-3 Months, will be collected at 3 month visit
Quality of Life Questionnaire- PedEyeQ
Time Frame: 3-6 Months, will be collected at 6 month visit
Quality of life measures using the PedEyeQ
3-6 Months, will be collected at 6 month visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Children's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fitz Frames, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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