Clinical Data Registry of Amblyopia Patients on Luminopia Treatment
- Conditions
- Amblyopia
- Registration Number
- NCT06429280
- Lead Sponsor
- Luminopia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Have a diagnosis of amblyopia
- Have undergone or currently undergoing Luminopia treatment for a minimum of 12 weeks
-Have participated in prior Luminopia clinical trials
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adherence with Luminopia treatment 3, 6,12, 24 months Adherence with Luminopia treatment
Durability of Visual Acuity results post-treatment cessation 3, 6,12, 24 months Durability of Visual Acuity results post-treatment cessation
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
Change in Stereoacuity from baseline to consecutive visits 3, 6,12, 24 months Change in Stereoacuity from baseline to consecutive visits
- Secondary Outcome Measures
Name Time Method 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 Age 3, 6,12, 24 months Visual Acuity Analyses will also be conducted by Age
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 Severity (Baseline Visual Acuity) 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 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 Baseline Angle of Deviation 3, 6,12, 24 months Visual Acuity analyses will also be conducted by Baseline Angle of Deviation
Trial Locations
- Locations (13)
Sansum Clinic
๐บ๐ธSanta Barbara, California, United States
Lurie Children's Hospital
๐บ๐ธChicago, Illinois, United States
Family Focus Eye Care
๐บ๐ธGainesville, Florida, United States
Eye Physicians of Central Florida
๐บ๐ธMaitland, Florida, United States
Riley Children's Hospital at IU Health
๐บ๐ธIndianapolis, Indiana, United States
Nevada Eye Physicians
๐บ๐ธLas Vegas, Nevada, United States
Honolulu Eye Clinic
๐บ๐ธHonolulu, Hawaii, United States
UCSF Benioff Children's Physicians
๐บ๐ธSan Ramon, California, United States
Children's Eye Institute of Savannah
๐บ๐ธSavannah, Georgia, United States
Okaloosa Ophthalmology
๐บ๐ธCrestview, Florida, United States
Concord Eye Center
๐บ๐ธConcord, New Hampshire, United States
Children's Hospital Of Philadelphia
๐บ๐ธPhiladelphia, Pennsylvania, United States
Pediatric Eye Specialist
๐บ๐ธFort Worth, Texas, United States