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临床试验/NCT05588362
NCT05588362尚未招募不适用

Access to EyeGlasses for School-aged Children

Boston Children's Hospital0 个研究点目标入组 72 人开始时间: 2023年2月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emily Wiecek

Optometrist

Boston Children's Hospital

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