AmblyopiaNCT03608150
Luminopia One Amblyopia Vision Improvement Study
A study testing Luminopia One and Refractive Correction in people with Amblyopia, run by Luminopia at 22 sites in United States.
Trial summary
The objective of the study is to demonstrate the safety and efficacy of Luminopia One in amblyopia patients with amblyopia associated with anisometropia and/or with mild strabismus. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Luminopia One and Refractive Correction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 22 sitesUnited States
- Study dates
- 16 Jan 2019to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 4 to 7 years at the time of consent.
- Amblyopia associated with anisometropia and/or mild strabismus.
- Current refractive correction worn for at least 16 weeks or until 2 consecutive visual acuity measurements at least 8 weeks apart do not change by more than 1 logMAR lines.
- Amblyopic eye best-corrected visual acuity (BCVA) 20/40 to 20/200 inclusive.
- Fellow eye BCVA 20/32 or better.
- Interocular difference ≥ 3 logMAR lines.
- Heterotropia ≤ 5 prism diopters in current refractive correction at distance measured by SPCT.
Who cannot join
- Atropine treatment in the past 2 weeks.
- Prior amblyopia treatment (other than refractive correction) for > 12 months in total.
- High myopia, previous intraocular / refractive surgery, severe ocular co-morbidities or development / cognitive delay.
- History of low adherence with amblyopia treatment or light-induced seizures.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Specialized Pediatric Eye Care
Beverly, Massachusetts, 01915
IU School of Optometry
Bloomington, Indiana, 47405
Lurie Children's Hospital
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
OSU College of Optometry
Columbus, Ohio, 43210
Children's Eye Care of Michigan
Dearborn, Michigan, 48124
Duke University
Durham, North Carolina, 27708
Pediatric Ophthalmology of Erie
Erie, Pennsylvania, 16501
Kids Eye Care of Maryland
Frederick, Maryland, 21703
Family Focus Eye Care
Gainesville, Florida, 32605
Houston Eye Associates
Houston, Texas, 77025
Texas Children's Hospital (BCM)
Houston, Texas, 77030
Houston Eye Associates
Houston, Texas, 77381
Conestoga Eye
Lancaster, Pennsylvania, 17601
UCLA Jules Stein Eye Institute
Los Angeles, California, 90095
Eye Physicians of Central Florida
Maitland, Florida, 32751
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Children's Hospital Of Philadelphia
Philadelphia, Pennsylvania, 19104
Rocky Mountain Eye Care
Salt Lake City, Utah, 84107
Tri-County Eye Physicians
Southampton, Pennsylvania, 18966
Saint Louis University
St Louis, Missouri, 63104
Virginia Pediatric Eye Center
Virginia Beach, Virginia, 23452
About this study
The objective of the study is to demonstrate the safety and efficacy of Luminopia One in amblyopia patients with amblyopia associated with anisometropia and/or with mild strabismus.
Read the detailed description
The proposed study is a multi-center randomized controlled clinical trial which compares the mean change in amblyopic eye Best Corrected Visual Acuity from baseline with Luminopia One ("therapeutic") to refractive correction ("control"). One-hundred and forty participants (n = 140) aged 4-7 years will be enrolled. Participants will be randomized 1:1 to the "therapeutic group ", to use Luminopia One, or the "control group", to undergo continued refractive correction, for 12 weeks of treatment.
- Conditions
- Amblyopia
- Being tested
- Luminopia One, Refractive Correction
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luminopia OneDevice
Luminopia One is a virtual-reality based digital therapeutic that applies therapeutic modifications in real-time to cinematic content to rebalance visual input and treat amblyopia.
Refractive CorrectionDevice
Standard of care refractive correction (ex. spectacles)
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Group | Experimental | Participants assigned to the therapeutic group will be prescribed Luminopia One for 1 hour per day, 6 days per week for 12 weeks. Receives: Device: Luminopia One |
| Control Group | Active comparator | Participants assigned to the control group will wear their current refractive correction full-time for 12 weeks. Receives: Device: Refractive Correction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-Corrected Visual Acuity of Amblyopic Eye
Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol.
Measured: 12 weeks
Best-Corrected Visual Acuity of Fellow Eye
Mean improvement in best-corrected visual acuity of fellow eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol.
Measured: 12 weeks
Secondary outcomes (4)
Adherence
Mean adherence with the therapeutic in treatment group.
Measured: 12 weeks
Best-Corrected Visual Acuity of Amblyopic Eye
Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 4 weeks using electronic ATS-HOTV protocol.
Measured: 4 weeks
Best-Corrected Visual Acuity of Amblyopic Eye
Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 8 weeks using electronic ATS-HOTV protocol.
Measured: 8 weeks
Stereoacuity
Mean stereoacuity improvement from baseline after 12 weeks.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start16 Jan 2019
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luminopia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Xiao, Study director, Luminopia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608150
- Sponsor's protocol ID
- C-AM-2
- Status last verified
- Feb 2024
- First submitted
- 12 Jul 2018
- Last updated
- 20 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Luminopia One Amblyopia Vision Improvement Study
- ClinicalTrials.gov ID
- NCT03608150
- Acronym / sponsor ID
- C-AM-2
- Conditions
- Amblyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- LuminopiaIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Posted 20 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to demonstrate the safety and efficacy of Luminopia One in amblyopia patients with amblyopia associated with anisometropia and/or with mild strabismus.
Detailed description
The proposed study is a multi-center randomized controlled clinical trial which compares the mean change in amblyopic eye Best Corrected Visual Acuity from baseline with Luminopia One ("therapeutic") to refractive correction ("control"). One-hundred and forty participants (n = 140) aged 4-7 years will be enrolled. Participants will be randomized 1:1 to the "therapeutic group ", to use Luminopia One, or the "control group", to undergo continued refractive correction, for 12 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Group | Experimental | Device: Luminopia OneParticipants assigned to the therapeutic group will be prescribed Luminopia One for 1 hour per day, 6 days per week for 12 weeks. |
| Control Group | Active comparator | Device: Refractive CorrectionParticipants assigned to the control group will wear their current refractive correction full-time for 12 weeks. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age 4 to 7 years at the time of consent.
- Amblyopia associated with anisometropia and/or mild strabismus.
- Current refractive correction worn for at least 16 weeks or until 2 consecutive visual acuity measurements at least 8 weeks apart do not change by more than 1 logMAR lines.
- Amblyopic eye best-corrected visual acuity (BCVA) 20/40 to 20/200 inclusive.
- Fellow eye BCVA 20/32 or better.
Key exclusion criteria (4 listed)
- Atropine treatment in the past 2 weeks.
- Prior amblyopia treatment (other than refractive correction) for > 12 months in total.
- High myopia, previous intraocular / refractive surgery, severe ocular co-morbidities or development / cognitive delay.
- History of low adherence with amblyopia treatment or light-induced seizures.
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 |
|---|---|---|
| Luminopia OneLuminopia One is a virtual-reality based digital therapeutic that applies therapeutic modifications in real-time to cinematic content to rebalance visual input and treat amblyopia. | Device | Therapeutic Group |
| Refractive CorrectionStandard of care refractive correction (ex. spectacles) | Device | Control Group |
Primary outcome
Best-Corrected Visual Acuity of Amblyopic Eye
Time frame: 12 weeks
Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol.
Best-Corrected Visual Acuity of Fellow Eye
Time frame: 12 weeks
Mean improvement in best-corrected visual acuity of fellow eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol.
4 secondary outcomes
Adherence
Time frame: 12 weeks
Best-Corrected Visual Acuity of Amblyopic Eye
Time frame: 4 weeks
Best-Corrected Visual Acuity of Amblyopic Eye
Time frame: 8 weeks
Stereoacuity
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Scott Xiao study director
Luminopia
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Luminopia One and Refractive Correction in people with Amblyopia, run by Luminopia at 22 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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?
Yes. Results are posted in the registry (first posted 20 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best-Corrected Visual Acuity of Amblyopic Eye (time frame: 12 weeks). The study lists 2 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 20 Mar 2024.