Clinical Data Registry of Amblyopia Patients on Luminopia Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 13
- 主要终点
- Change in Stereoacuity from baseline to consecutive visits
研究概览
简要总结
Amblyopia is the most prevalent cause of reduced monocular visual acuity in children and young adults, with estimates of prevalence ranging from 1% to 5%. The most common associated amblyogenic risk factors are uncorrected anisometropia, strabismus, or a combination of these. In addition to reduced visual acuity, amblyopic patients may also have measurable dysfunction of accommodation, fixation, binocularity, vergence, reading fluency, depth perception, and contrast sensitivity.
For the first time since the incorporation of atropine penalization into amblyopia management, physicians can now offer Luminopia, an FDA-approved dual action dichoptic treatment, to patients with amblyopia. Since the product became commercially available in November 2022, the number of patients on Luminopia therapy continues to grow. This presents a unique opportunity to gather real world evidence from a large number of patients, representative of how ophthalmologists and optometrists are applying this novel treatment in the real world. A registry of the clinical data associated with Luminopia treatment, with IRB oversight, will provide answers to key scientific questions using a large dataset.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of amblyopia
- •Have undergone or currently undergoing Luminopia treatment for a minimum of 12 weeks
排除标准
- •Have participated in prior Luminopia clinical trials
结局指标
主要结局
Change in Stereoacuity from baseline to consecutive visits
时间窗: 3, 6,12, 24 months
Change in Stereoacuity from baseline to consecutive visits
Adherence with Luminopia treatment
时间窗: 3, 6,12, 24 months
Adherence with Luminopia treatment
Durability of Visual Acuity results post-treatment cessation
时间窗: 3, 6,12, 24 months
Durability of Visual Acuity results post-treatment cessation
Change in Visual Acuity from baseline to consecutive visits
时间窗: 3, 6,12, 24 months
Change in Visual Acuity from baseline to consecutive visits
Duration of Visual Acuity treatment and number of follow-up visits
时间窗: 3, 6,12, 24 months
Duration of Visual Acuity treatment and number of follow-up visits
次要结局
- Visual Acuity analyses will also be conducted by Adherence to Treatment(3, 6,12, 24 months)
- Visual Acuity analyses will also be conducted by Prior Treatment(3, 6,12, 24 months)
- Visual Acuity Analyses will also be conducted by Age(3, 6,12, 24 months)
- Visual Acuity analyses will also be conducted by Amblyopia Type(3, 6,12, 24 months)
- Visual Acuity analyses will also be conducted by Severity (Baseline Visual Acuity)(3, 6,12, 24 months)
- Visual Acuity Analyses will also be conducted by Prescribed Dose(3, 6,12, 24 months)
- Visual Acuity analyses will also be conducted by Baseline Angle of Deviation(3, 6,12, 24 months)
