Access to EyeGlasses for School-aged Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 主要终点
- Compliance
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 5 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •strabismus
- •developmental or learning delay
- •other ocular pathology
结局指标
主要结局
Compliance
时间窗: Six months
Glasses compliance will be assessed with self-reported calendar
Quality of Life Questionnaire
时间窗: Baseline, will be collected at enrollment visit
Quality of life measures using the PedEyeQ
Distance visual acuity
时间窗: 3-6 Months, will be collected at 6 month visit
Linear Snellen optotypes (age \>6) or HOTV matching with crowding bars (age \<6)
Stereoacuity
时间窗: 3-6 Months, will be collected at 6 month visit
Stereo Fly test
Ocular alignment
时间窗: 3-6 Months, will be collected at 6 month visit
Alternative prism cover test at distance and at near
Near point of convergence
时间窗: 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
时间窗: 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
时间窗: 3-6 Months, will be collected at 6 month visit
Quality of life measures using the PedEyeQ
次要结局
未报告次要终点
研究者
Emily Wiecek
Optometrist
Boston Children's Hospital
