跳至主要内容
临床试验/NCT06429280
NCT06429280招募中不适用

Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

Luminopia13 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年9月1日最近更新:
适应症

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

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)

研究者

发起方
Luminopia
申办方类型
Industry
责任方
Sponsor

研究点 (13)

Loading locations...

相似试验

相关资讯