N/A this is an observational study of Standard of Care
DeviceMedical Device which treats unilateral amblyopia through therapeutic software which stimulate vision
NCT Number: NCT06429280
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.
Interested in participating?
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Observational
UCSF Benioff Children's Physicians, San Ramon, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-Have participated in prior Luminopia clinical trials
Medical Device which treats unilateral amblyopia through therapeutic software which stimulate vision
Time frame: 3, 6,12, 24 months
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
Time frame: 3, 6,12, 24 months
Durability of Visual Acuity results post-treatment cessation
Time frame: 3, 6,12, 24 months
Adherence with Luminopia treatment
Time frame: 3, 6,12, 24 months
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
Time frame: 3, 6,12, 24 months
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
Time frame: 3, 6,12, 24 months
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)
Time frame: 3, 6,12, 24 months
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
Luminopia
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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