Amblyopia
Conditions
Brief summary
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.
Interventions
DEVICEN/A this is an observational study of Standard of Care
Medical Device which treats unilateral amblyopia through therapeutic software which stimulate vision
Sponsors
Luminopia
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of amblyopia * Have undergone or currently undergoing Luminopia treatment for a minimum of 12 weeks
Exclusion criteria
-Have participated in prior Luminopia clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Stereoacuity from baseline to consecutive visits | 3, 6,12, 24 months | Change in Stereoacuity from baseline to consecutive visits |
| Adherence with Luminopia treatment | 3, 6,12, 24 months | Adherence with Luminopia treatment |
| Change in Visual Acuity from baseline to consecutive visits | 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 | 3, 6,12, 24 months | Duration of Visual Acuity treatment and number of follow-up visits |
| Durability of Visual Acuity results post-treatment cessation | 3, 6,12, 24 months | Durability of Visual Acuity results post-treatment cessation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity analyses will also be conducted by Adherence to Treatment | 3, 6,12, 24 months | Visual Acuity analyses will also be conducted by Adherence to Treatment |
| Visual Acuity analyses will also be conducted by Prior Treatment | 3, 6,12, 24 months | Visual Acuity analyses will also be conducted by Prior Treatment |
| Visual Acuity Analyses will also be conducted by Prescribed Dose | 3, 6,12, 24 months | Visual Acuity Analyses will also be conducted by Prescribed Dose |
| Visual Acuity analyses will also be conducted by Amblyopia Type | 3, 6,12, 24 months | Visual Acuity analyses will also be conducted by Amblyopia Type |
| Visual Acuity Analyses will also be conducted by Age | 3, 6,12, 24 months | Visual Acuity Analyses will also be conducted by Age |
| Visual Acuity analyses will also be conducted by Baseline Angle of Deviation | 3, 6,12, 24 months | Visual Acuity analyses will also be conducted by Baseline Angle of Deviation |
| 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 Severity (Baseline Visual Acuity) |
Countries
United States
Outcome results
None listed