Clinical trial NCT06429280: Clinical Data Registry of Amblyopia Patients on Luminopia Treatment
Official title: Clinical Data Registry of Amblyopia Patients on Luminopia Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amblyopia
Lead sponsor: Luminopia
Sponsor class: INDUSTRY
First posted: 2024-05-24
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of Amblyopia

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Visual Acuity from baseline to consecutive visits
timeFrame: 3, 6,12, 24 months
measure: Duration of Visual Acuity treatment and number of follow-up visits
timeFrame: 3, 6,12, 24 months
measure: Durability of Visual Acuity results post-treatment cessation
timeFrame: 3, 6,12, 24 months
measure: Adherence with Luminopia treatment
timeFrame: 3, 6,12, 24 months
measure: Change in Stereoacuity from baseline to consecutive visits
timeFrame: 3, 6,12, 24 months
Secondary outcomes:
measure: Visual Acuity analyses will also be conducted by Prior Treatment
timeFrame: 3, 6,12, 24 months
measure: Visual Acuity analyses will also be conducted by Amblyopia Type
timeFrame: 3, 6,12, 24 months
measure: Visual Acuity Analyses will also be conducted by Age
timeFrame: 3, 6,12, 24 months
measure: Visual Acuity analyses will also be conducted by Baseline Angle of Deviation
timeFrame: 3, 6,12, 24 months
measure: Visual Acuity analyses will also be conducted by Severity (Baseline Visual Acuity)
timeFrame: 3, 6,12, 24 months
measure: Visual Acuity analyses will also be conducted by Adherence to Treatment
timeFrame: 3, 6,12, 24 months
measure: Visual Acuity Analyses will also be conducted by Prescribed Dose
timeFrame: 3, 6,12, 24 months
Other outcomes:
Locations:
city: San Ramon
country: United States
facility: UCSF Benioff Children's Physicians
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic
state: California
city: Crestview
country: United States
facility: Okaloosa Ophthalmology
state: Florida
city: Gainesville
country: United States
facility: Family Focus Eye Care
state: Florida
city: Maitland
country: United States
facility: Eye Physicians of Central Florida
state: Florida
city: Savannah
country: United States
facility: Children's Eye Institute of Savannah
state: Georgia
city: Honolulu
country: United States
facility: Honolulu Eye Clinic
state: Hawaii
city: Chicago
country: United States
facility: Lurie Children's Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Riley Children's Hospital at IU Health
state: Indiana
city: Las Vegas
country: United States
facility: Nevada Eye Physicians
state: Nevada
city: Concord
country: United States
facility: Concord Eye Center
state: New Hampshire
city: Philadelphia
country: United States
facility: Children's Hospital Of Philadelphia
state: Pennsylvania
city: Fort Worth
country: United States
facility: Pediatric Eye Specialist
state: Texas
Study officials:
References: