Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429280
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-02-23
Brief Title:
Clinical Data Registry of Amblyopia Patients on Luminopia Treatment
Sponsor:
Luminopia
Organization:
Luminopia
Study Overview
Official Title:
Clinical Data Registry of Amblyopia Patients on Luminopia Treatment
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None