Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

ConditionAmblyopia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorLuminopia

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Have a diagnosis of amblyopia

Have undergone or currently undergoing Luminopia treatment for a minimum of 12 weeks

Disqualifiers

None

Trial population

Patients with a diagnosis of Amblyopia

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • N/A this is an observational study of Standard of Care

    Device

    Medical Device which treats unilateral amblyopia through therapeutic software which stimulate vision

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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
2

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
3

Durability of Visual Acuity results post-treatment cessation

Durability of Visual Acuity results post-treatment cessation

Time frame
3, 6,12, 24 months
4

Adherence with Luminopia treatment

Adherence with Luminopia treatment

Time frame
3, 6,12, 24 months

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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