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NCT Number: NCT06429280

Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

UCSF Benioff Children's Physicians, San Ramon, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Primary outcomes

  1. Change in Visual Acuity from baseline to consecutive visits

    Time frame: 3, 6,12, 24 months

    Change in Visual Acuity from baseline to consecutive visits

  2. Duration of Visual Acuity treatment and number of follow-up visits

    Time frame: 3, 6,12, 24 months

    Duration of Visual Acuity treatment and number of follow-up visits

  3. Durability of Visual Acuity results post-treatment cessation

    Time frame: 3, 6,12, 24 months

    Durability of Visual Acuity results post-treatment cessation

  4. Adherence with Luminopia treatment

    Time frame: 3, 6,12, 24 months

    Adherence with Luminopia treatment

  5. Change in Stereoacuity from baseline to consecutive visits

    Time frame: 3, 6,12, 24 months

    Change in Stereoacuity from baseline to consecutive visits

Secondary outcomes

  1. Visual Acuity analyses will also be conducted by Prior Treatment

    Time frame: 3, 6,12, 24 months

    Visual Acuity analyses will also be conducted by Prior Treatment

  2. Visual Acuity analyses will also be conducted by Amblyopia Type

    Time frame: 3, 6,12, 24 months

    Visual Acuity analyses will also be conducted by Amblyopia Type

  3. Visual Acuity Analyses will also be conducted by Age

    Time frame: 3, 6,12, 24 months

    Visual Acuity Analyses will also be conducted by Age

  4. Visual Acuity analyses will also be conducted by Baseline Angle of Deviation

    Time frame: 3, 6,12, 24 months

    Visual Acuity analyses will also be conducted by Baseline Angle of Deviation

  5. Visual Acuity analyses will also be conducted by Severity (Baseline Visual Acuity)

    Time frame: 3, 6,12, 24 months

    Visual Acuity analyses will also be conducted by Severity (Baseline Visual Acuity)

  6. Visual Acuity analyses will also be conducted by Adherence to Treatment

    Time frame: 3, 6,12, 24 months

    Visual Acuity analyses will also be conducted by Adherence to Treatment

  7. Visual Acuity Analyses will also be conducted by Prescribed Dose

    Time frame: 3, 6,12, 24 months

    Visual Acuity Analyses will also be conducted by Prescribed Dose

Sponsors and collaborators

Lead sponsor

Luminopia

Industry

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 24, 2024
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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