Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

Amblyopia Clinical Trial

Official title:

Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06429280
• Other study ID #: R-AM-1
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: December 1, 2026

Study information

• Verified date: May 2024
• Source: Luminopia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Amblyopia

Intervention

Device:
• N/A this is an observational study of Standard of Care
Medical Device which treats unilateral amblyopia through therapeutic software which stimulate vision

Locations

Country	Name	City	State
United States	Lurie Children's Hospital	Chicago	Illinois
United States	Concord Eye Center	Concord	New Hampshire
United States	Okaloosa Ophthalmology	Crestview	Florida
United States	Pediatric Eye Specialist	Fort Worth	Texas
United States	Family Focus Eye Care	Gainesville	Florida
United States	Honolulu Eye Clinic	Honolulu	Hawaii
United States	Riley Children's Hospital at IU Health	Indianapolis	Indiana
United States	Nevada Eye Physicians	Las Vegas	Nevada
United States	Eye Physicians of Central Florida	Maitland	Florida
United States	Children's Hospital Of Philadelphia	Philadelphia	Pennsylvania
United States	UCSF Benioff Children's Physicians	San Ramon	California
United States	Sansum Clinic	Santa Barbara	California
United States	Children's Eye Institute of Savannah	Savannah	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Luminopia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Visual Acuity from baseline to consecutive visits	Change in Visual Acuity from baseline to consecutive visits	3, 6,12, 24 months
Primary	Duration of Visual Acuity treatment and number of follow-up visits	Duration of Visual Acuity treatment and number of follow-up visits	3, 6,12, 24 months
Primary	Durability of Visual Acuity results post-treatment cessation	Durability of Visual Acuity results post-treatment cessation	3, 6,12, 24 months
Primary	Adherence with Luminopia treatment	Adherence with Luminopia treatment	3, 6,12, 24 months
Primary	Change in Stereoacuity from baseline to consecutive visits	Change in Stereoacuity from baseline to consecutive visits	3, 6,12, 24 months
Secondary	Visual Acuity analyses will also be conducted by Prior Treatment	Visual Acuity analyses will also be conducted by Prior Treatment	3, 6,12, 24 months
Secondary	Visual Acuity analyses will also be conducted by Amblyopia Type	Visual Acuity analyses will also be conducted by Amblyopia Type	3, 6,12, 24 months
Secondary	Visual Acuity Analyses will also be conducted by Age	Visual Acuity Analyses will also be conducted by Age	3, 6,12, 24 months
Secondary	Visual Acuity analyses will also be conducted by Baseline Angle of Deviation	Visual Acuity analyses will also be conducted by Baseline Angle of Deviation	3, 6,12, 24 months
Secondary	Visual Acuity analyses will also be conducted by Severity (Baseline Visual Acuity)	Visual Acuity analyses will also be conducted by Severity (Baseline Visual Acuity)	3, 6,12, 24 months
Secondary	Visual Acuity analyses will also be conducted by Adherence to Treatment	Visual Acuity analyses will also be conducted by Adherence to Treatment	3, 6,12, 24 months
Secondary	Visual Acuity Analyses will also be conducted by Prescribed Dose	Visual Acuity Analyses will also be conducted by Prescribed Dose	3, 6,12, 24 months