An observational study in Amblyopia, sponsored by Luminopia. Recruiting at 13 sites in United States. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Luminopia · Observational
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.
189 studies on the registry are indexed under Amblyopia; 41 are open to participants now.
This study's planned enrollment of 500 is above the median of 156 across 39 observational studies indexed under Amblyopia.
Browse Amblyopia studies →Luminopia is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with a diagnosis of Amblyopia
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
-Have participated in prior Luminopia clinical trials
Medical Device which treats unilateral amblyopia through therapeutic software which stimulate vision
Change in Visual Acuity from baseline to consecutive visits
Change in Visual Acuity from baseline to consecutive visits
Time frame: 3, 6,12, 24 months
Duration of Visual Acuity treatment and number of follow-up visits
Duration of Visual Acuity treatment and number of follow-up visits
Time frame: 3, 6,12, 24 months
Durability of Visual Acuity results post-treatment cessation
Durability of Visual Acuity results post-treatment cessation
Time frame: 3, 6,12, 24 months
Adherence with Luminopia treatment
Adherence with Luminopia treatment
Time frame: 3, 6,12, 24 months
Change in Stereoacuity from baseline to consecutive visits
Change in Stereoacuity from baseline to consecutive visits
Time frame: 3, 6,12, 24 months
Visual Acuity analyses will also be conducted by Prior Treatment
Visual Acuity analyses will also be conducted by Prior Treatment
Time frame: 3, 6,12, 24 months
Visual Acuity analyses will also be conducted by Amblyopia Type
Visual Acuity analyses will also be conducted by Amblyopia Type
Time frame: 3, 6,12, 24 months
Visual Acuity Analyses will also be conducted by Age
Visual Acuity Analyses will also be conducted by Age
Time frame: 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 Baseline Angle of Deviation
Time frame: 3, 6,12, 24 months
Visual Acuity analyses will also be conducted by Severity (Baseline Visual Acuity)
Visual Acuity analyses will also be conducted by Severity (Baseline Visual Acuity)
Time frame: 3, 6,12, 24 months
Visual Acuity analyses will also be conducted by Adherence to Treatment
Visual Acuity analyses will also be conducted by Adherence to Treatment
Time frame: 3, 6,12, 24 months
Visual Acuity Analyses will also be conducted by Prescribed Dose
Visual Acuity Analyses will also be conducted by Prescribed Dose
Time frame: 3, 6,12, 24 months
Plan to share: No
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No contact was published for this record. The registry link below has the sponsor’s details.
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