MyopiaATEGNCT05588362
Access to EyeGlasses for School-aged Children
A study testing Fitz Frames 3-D Printed Glasses in people with Myopia and Amblyopia, run by Boston Children's Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 5 to 17 years
- What is being tested?
- Fitz Frames 3-D Printed Glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- strabismus
- developmental or learning delay
- other ocular pathology
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02118
About this study
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
- Being tested
- Fitz Frames 3-D Printed Glasses
- Medical subject headings
- Myopia, Amblyopia, Hyperopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitz Frames 3-D Printed GlassesOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance
Glasses compliance will be assessed with self-reported calendar
Measured: Six months
Quality of Life Questionnaire
Quality of life measures using the PedEyeQ
Measured: Baseline, will be collected at enrollment visit
Distance visual acuity
Linear Snellen optotypes (age >6) or HOTV matching with crowding bars (age <6)
Measured: Baseline, will be collected at enrollment visit
Distance visual acuity
Linear Snellen optotypes (age >6) or HOTV matching with crowding bars (age <6)
Measured: 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)
Measured: 3-6 Months, will be collected at 6 month visit
Stereoacuity
Stereo Fly test
Measured: Baseline, will be collected at enrollment visit
Stereoacuity
Stereo Fly test
Measured: 0-3 Months, will be collected at 3 month visit
Stereoacuity
Stereo Fly test
Measured: 3-6 Months, will be collected at 6 month visit
Ocular alignment
Alternative prism cover test at distance and at near
Measured: Baseline, will be collected at enrollment visit
Ocular alignment
Alternative prism cover test at distance and at near
Measured: 0-3 Months, will be collected at 3 month visit
Ocular alignment
Alternative prism cover test at distance and at near
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, will be collected at enrollment visit
Near visual acuity
Near visual acuity will be measured at 40 cm using the Rosenbaum card
Measured: 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
Measured: 3-6 Months, will be collected at 6 month visit
Quality of Life Questionnaire- PedEyeQ
Quality of life measures using the PedEyeQ
Measured: 0-3 Months, will be collected at 3 month visit
Quality of Life Questionnaire- PedEyeQ
Quality of life measures using the PedEyeQ
Measured: 3-6 Months, will be collected at 6 month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start1 Apr 2024
- Primary completion30 May 2025
- Study completion30 May 2025
Why it stopped: Funding was stopped from source before project could start intervention phase of trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized control study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fitz Frames, Inc.
- Responsible party
- Principal investigator, Emily Wiecek, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588362
- Sponsor's protocol ID
- IRB-P00040587
- Acronym
- ATEG
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2022
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Access to EyeGlasses for School-aged Children
- ClinicalTrials.gov ID
- NCT05588362
- Acronym / sponsor ID
- ATEG / IRB-P00040587
- Conditions
- Myopia, Amblyopia, Hyperopia, Refractive Errors
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding was stopped from source before project could start intervention phase of trial
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Fitz Frames, Inc.
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized control study
| Arm | Type | Receives |
|---|---|---|
| Fitz Frames 3-D Printed Glasses | Experimental | Other: Fitz Frames 3-D Printed GlassesThe 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). |
| 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. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- strabismus
- developmental or learning delay
- other ocular pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitz Frames 3-D Printed GlassesThe 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 |
Primary outcome
Compliance
Time frame: Six months
Glasses compliance will be assessed with self-reported calendar
Quality of Life Questionnaire
Time frame: Baseline, will be collected at enrollment visit
Quality of life measures using the PedEyeQ
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)
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)
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)
Stereoacuity
Time frame: Baseline, will be collected at enrollment visit
Stereo Fly test
Stereoacuity
Time frame: 0-3 Months, will be collected at 3 month visit
Stereo Fly test
Stereoacuity
Time frame: 3-6 Months, will be collected at 6 month visit
Stereo Fly test
Ocular alignment
Time frame: Baseline, will be collected at enrollment visit
Alternative prism cover test at distance and at near
Ocular alignment
Time frame: 0-3 Months, will be collected at 3 month visit
Alternative prism cover test at distance and at near
Ocular alignment
Time frame: 3-6 Months, will be collected at 6 month visit
Alternative prism cover test at distance and at near
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
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
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
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
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
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
Quality of Life Questionnaire- PedEyeQ
Time frame: 0-3 Months, will be collected at 3 month visit
Quality of life measures using the PedEyeQ
Quality of Life Questionnaire- PedEyeQ
Time frame: 3-6 Months, will be collected at 6 month visit
Quality of life measures using the PedEyeQ
Results and safety
The study was stopped early (reason given: Funding was stopped from source before project could start intervention phase of trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitz Frames 3-D Printed Glasses in people with Myopia and Amblyopia, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding was stopped from source before project could start intervention phase of trial). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance (time frame: Six months). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.