AmblyopiaNCT06429280
Clinical Data Registry of Amblyopia Patients on Luminopia Treatment
An observational study of Amblyopia, run by Luminopia at 13 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Amblyopia
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 13 sitesUnited States
- Study dates
- 1 Sep 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a diagnosis of Amblyopia
Who may be able to join
- Have a diagnosis of amblyopia
- Have undergone or currently undergoing Luminopia treatment for a minimum of 12 weeks
Who cannot join
- -Have participated in prior Luminopia clinical trials
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
Lurie Children's Hospital
Chicago, Illinois, 60611
Endri Angjeli, 9788067080, endri@luminopia.com
- Recruiting
Concord Eye Center
Concord, New Hampshire, 03301
Endri Angjeli, 9788067080, endri@luminopia.com
- Recruiting
Okaloosa Ophthalmology
Crestview, Florida, 32536
Endri Angjeli, 9788067080, endri@luminopia.com
- Recruiting
Pediatric Eye Specialist
Fort Worth, Texas, 76104
Endri Angjeli, 9788067080, endri@luminopia.com
- Recruiting
Family Focus Eye Care
Gainsville, Florida, 32605
Endri Angjeli, 9788067080, endri@luminopia.com
- Recruiting
Honolulu Eye Clinic
Honolulu, Hawaii, 96813
Endri Angjeli, 9788067080, endri@luminopia.com
- Recruiting
Riley Children's Hospital at IU Health
Indianapolis, Indiana, 46202
Endri Angjeli, 9788067080, endri@luminopia.com
- Recruiting
Nevada Eye Physicians
Las Vegas, Nevada, 89149
Endri Angjeli, 9788067080, endri@luminopia.com
- Recruiting
Eye Physicians of Central Florida
Maitland, Florida, 32751
Endri Angjeli, 9788067080, endri@luminopia.com
Louis Blumenfeld
- Recruiting
Children's Hospital Of Philadelphia
Philadelphia, Pennsylvania, 19104
Endri Angjeli, 9788067080, endri@luminopia.com
- Recruiting
UCSF Benioff Children's Physicians
San Ramon, California, 94583
Endri Angjeli, 9788067080, endria@luminopia.com
- Recruiting
Sansum Clinic
Santa Barbara, California, 93110
Endri Angjeli, 9788067080, endri@luminopia.com
- Recruiting
Children's Eye Institute of Savannah
Savannah, Georgia, 31406
Endri Angjeli, 9788067080, endri@luminopia.com
About this study
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.
- Conditions
- Amblyopia
- Being tested
- N/A this is an observational study of Standard of Care
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N/A this is an observational study of Standard of CareDevice
Medical Device which treats unilateral amblyopia through therapeutic software which stimulate vision
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Acuity from baseline to consecutive visits
Change in Visual Acuity from baseline to consecutive visits
Measured: 3, 6,12, 24 months
Duration of Visual Acuity treatment and number of follow-up visits
Duration of Visual Acuity treatment and number of follow-up visits
Measured: 3, 6,12, 24 months
Durability of Visual Acuity results post-treatment cessation
Durability of Visual Acuity results post-treatment cessation
Measured: 3, 6,12, 24 months
Adherence with Luminopia treatment
Adherence with Luminopia treatment
Measured: 3, 6,12, 24 months
Change in Stereoacuity from baseline to consecutive visits
Change in Stereoacuity from baseline to consecutive visits
Measured: 3, 6,12, 24 months
Secondary outcomes (7)
Visual Acuity analyses will also be conducted by Prior Treatment
Visual Acuity analyses will also be conducted by Prior Treatment
Measured: 3, 6,12, 24 months
Visual Acuity analyses will also be conducted by Amblyopia Type
Visual Acuity analyses will also be conducted by Amblyopia Type
Measured: 3, 6,12, 24 months
Visual Acuity Analyses will also be conducted by Age
Visual Acuity Analyses will also be conducted by Age
Measured: 3, 6,12, 24 months
Visual Acuity analyses will also be conducted by Baseline Angle of Deviation
Visual Acuity analyses will also be conducted by Baseline Angle of Deviation
Measured: 3, 6,12, 24 months
Visual Acuity analyses will also be conducted by Severity (Baseline Visual Acuity)
Visual Acuity analyses will also be conducted by Severity (Baseline Visual Acuity)
Measured: 3, 6,12, 24 months
Visual Acuity analyses will also be conducted by Adherence to Treatment
Visual Acuity analyses will also be conducted by Adherence to Treatment
Measured: 3, 6,12, 24 months
Visual Acuity Analyses will also be conducted by Prescribed Dose
Visual Acuity Analyses will also be conducted by Prescribed Dose
Measured: 3, 6,12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luminopia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429280
- Sponsor's protocol ID
- R-AM-1
- Status last verified
- Sep 2025
- First submitted
- 23 Feb 2024
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Data Registry of Amblyopia Patients on Luminopia Treatment
- ClinicalTrials.gov ID
- NCT06429280
- Acronym / sponsor ID
- R-AM-1
- Conditions
- Amblyopia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- LuminopiaIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a diagnosis of Amblyopia
Key inclusion criteria (2 listed)
- Have a diagnosis of amblyopia
- Have undergone or currently undergoing Luminopia treatment for a minimum of 12 weeks
Key exclusion criteria (1 listed)
- -Have participated in prior Luminopia clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N/A this is an observational study of Standard of CareMedical Device which treats unilateral amblyopia through therapeutic software which stimulate vision | Device | – |
Primary outcome
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
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
Durability of Visual Acuity results post-treatment cessation
Time frame: 3, 6,12, 24 months
Durability of Visual Acuity results post-treatment cessation
Adherence with Luminopia treatment
Time frame: 3, 6,12, 24 months
Adherence with Luminopia treatment
Change in Stereoacuity from baseline to consecutive visits
Time frame: 3, 6,12, 24 months
Change in Stereoacuity from baseline to consecutive visits
7 secondary outcomes
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 Amblyopia Type
Time frame: 3, 6,12, 24 months
Visual Acuity Analyses will also be conducted by Age
Time frame: 3, 6,12, 24 months
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 Severity (Baseline Visual Acuity)
Time frame: 3, 6,12, 24 months
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 Prescribed Dose
Time frame: 3, 6,12, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Amblyopia
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
RecruitingPhase 3
Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
Amblyopia
RecruitingPhase 3
Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
Amblyopia
Recruiting
OCT Eccentric Fixation and Amblyopia in Children
Amblyopia
Not yet recruiting
Non-invasive Induction of Metaplasticity for Amblyopia
Amblyopia, Amblyopia Unilateral
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amblyopia, run by Luminopia at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Acuity from baseline to consecutive visits (time frame: 3, 6,12, 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.