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.
Study Type
OBSERVATIONAL
Enrollment
500
Medical Device which treats unilateral amblyopia through therapeutic software which stimulate vision
UCSF Benioff Children's Physicians
San Ramon, California, United States
RECRUITINGSansum Clinic
Santa Barbara, California, United States
RECRUITINGOkaloosa Ophthalmology
Crestview, Florida, United States
RECRUITINGFamily Focus Eye Care
Gainsville, Florida, United States
RECRUITINGEye Physicians of Central Florida
Maitland, Florida, United States
RECRUITINGChildren's Eye Institute of Savannah
Savannah, Georgia, United States
RECRUITINGHonolulu Eye Clinic
Honolulu, Hawaii, United States
RECRUITINGLurie Children's Hospital
Chicago, Illinois, United States
RECRUITINGRiley Children's Hospital at IU Health
Indianapolis, Indiana, United States
RECRUITINGNevada Eye Physicians
Las Vegas, Nevada, United States
RECRUITING...and 3 more locations
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
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