MyopiaNCT04415684
Projected Peripheral Defocus Using a Wearable Device
A study testing Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.) and No Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.) in people with Myopia, run by Kubota Vision Inc. at 1 site in United States.
Trial summary
Acucela Inc. intends to develop a medical device to significantly halt or reverse myopic progression, which is a significant public health concern across the world, especially in Asian demographics. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.) and No Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2020to 20 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Spherical equivalent +2.00 to -4.00 diopters
- Refractive cylinder ≤ 0.75 diopters
- Visual acuity 20/20 -3 or better
Who cannot join
- Pregnant or lactating
- Active ocular infection
- History of dry eye, strabismus, or amblyopia
- Previous or planned ocular surgery
- Use of medication known to affect vision or accommodation
Trial locations and contacts
1 site in 1 country.
United States1 site
Manhattan Vision Associates/institute of Vision Research
New York, New York, 10022
About this study
Official title: Effects of Projected Peripheral Defocus on Ocular Biometrics Using a Wearable Device
Acucela Inc. intends to develop a medical device to significantly halt or reverse myopic progression, which is a significant public health concern across the world, especially in Asian demographics. Acucela is working towards a spectacle-like device (eSPECs), which will have a clear zone for unimpeded central visual tasks and a periphery that provides defocus in order to alter retinal physiology leading to myopia regulation. This study will establish the changes seen during a proof-of-concept that projected defocus in the periphery utilizing a wearable device will stimulate physiological changes similar to those in the literature.
- Conditions
- Myopia
- Being tested
- Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.), No Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)Device
For the right/test eye, a defocused image is projected onto the peripheral retina while the subject views a distant, in-focus image
No Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)Device
For the left/control eye, no image is projected onto the peripheral retina. The subject views a distant, in-focus image.
| Study group | Role | What they receive |
|---|---|---|
| Test Arm | Experimental | Not described Receives: Device: Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.); Device: No Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length (AL)
Change in AL from baseline in the test eye vs. control eye
Measured: 1 hour
Choroidal thickness (CT)
Change in CT from baseline in the test eye vs. control eye
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start29 Jun 2020
- Primary completion20 Aug 2020
- Study completion20 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kubota Vision Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arkady Selenow, OD, Principal investigator, Manhattan Vision Associates/Institute of Vision Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415684
- Sponsor's protocol ID
- eSpec Phase III
- Status last verified
- Aug 2021
- First submitted
- 1 Jun 2020
- Last updated
- 20 Aug 2021
- Results posted
- No
- 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 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Projected Peripheral Defocus on Ocular Biometrics Using a Wearable Device
- ClinicalTrials.gov ID
- NCT04415684
- Acronym / sponsor ID
- eSpec Phase III
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Kubota Vision Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 4 Jun 2020 (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.
Acucela Inc. intends to develop a medical device to significantly halt or reverse myopic progression, which is a significant public health concern across the world, especially in Asian demographics. Acucela is working towards a spectacle-like device (eSPECs), which will have a clear zone for unimpeded central visual tasks and a periphery that provides defocus in order to alter retinal physiology leading to myopia regulation. This study will establish the changes seen during a proof-of-concept that projected defocus in the periphery utilizing a wearable device will stimulate physiological changes similar to those in the literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Arm | Experimental | Device: Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.), Device: No Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Spherical equivalent +2.00 to -4.00 diopters
- Refractive cylinder ≤ 0.75 diopters
- Visual acuity 20/20 -3 or better
Key exclusion criteria (5 listed)
- Pregnant or lactating
- Active ocular infection
- History of dry eye, strabismus, or amblyopia
- Previous or planned ocular surgery
- Use of medication known to affect vision or accommodation
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 |
|---|---|---|
| Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)For the right/test eye, a defocused image is projected onto the peripheral retina while the subject views a distant, in-focus image | Device | Test Arm |
| No Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)For the left/control eye, no image is projected onto the peripheral retina. The subject views a distant, in-focus image. | Device | Test Arm |
Primary outcome
Axial length (AL)
Time frame: 1 hour
Change in AL from baseline in the test eye vs. control eye
Choroidal thickness (CT)
Time frame: 1 hour
Change in CT from baseline in the test eye vs. control eye
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- 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.
Arkady Selenow, OD principal investigator
Manhattan Vision Associates/Institute of Vision Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.) and No Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.) in people with Myopia, run by Kubota Vision Inc. at 1 site 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 3 inclusion and 5 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 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Axial length (AL) (time frame: 1 hour). 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 Aug 2021.