About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have a diagnosis of amblyopia
Have undergone or currently undergoing Luminopia treatment for a minimum of 12 weeks
Disqualifiers
None
Trial population
Patients with a diagnosis of Amblyopia
Trial design
Cohort
Retrospective
Treatments tested in this trial
N/A this is an observational study of Standard of Care
DeviceMedical Device which treats unilateral amblyopia through therapeutic software which stimulate vision
Treatment groups
Trial outcomes
Primary outcomes
Change in Visual Acuity from baseline to consecutive visits
Change in Visual Acuity from baseline to consecutive visits
Duration of Visual Acuity treatment and number of follow-up visits
Duration of Visual Acuity treatment and number of follow-up visits
Durability of Visual Acuity results post-treatment cessation
Durability of Visual Acuity results post-treatment cessation
Adherence with Luminopia treatment
Adherence with Luminopia treatment
Secondary outcomes
Visual Acuity analyses will also be conducted by Prior Treatment
Visual Acuity analyses will also be conducted by Prior Treatment
Visual Acuity analyses will also be conducted by Amblyopia Type
Visual Acuity analyses will also be conducted by Amblyopia Type
Visual Acuity Analyses will also be conducted by Age
Visual Acuity Analyses will also be conducted by Age
Visual Acuity analyses will also be conducted by Baseline Angle of Deviation
Visual Acuity analyses will also be conducted by Baseline Angle of Deviation