MyopiaNCT04388020

Effects of Projected Peripheral Defocus on Ocular Biometrics

A study testing Tabletop prototype of eSpecs: Active projection of defocused image in the peripheral visual field and Tabletop prototype of eSpecs: No Active projection of defocused image in the peripheral visual field in people with Myopia, run by Kubota Vision Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: Tabletop prototype of eSpecs: Active projection of defocused image in the peripheral visual field and Tabletop prototype of eSpecs: No Active projection of defocused image in the peripheral visual field
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 11 Apr 2020to 14 May 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

Other trials in United States

About this study

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 will stimulate physiological changes similar to those in the literature.

Conditions: Myopia
Being tested: Tabletop prototype of eSpecs: Active projection of defocused image in the peripheral visual field, Tabletop prototype of eSpecs: No Active projection of defocused image in the peripheral visual field
Medical subject headings: Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tabletop prototype of eSpecs: Active projection of defocused image in the peripheral visual fieldDevice
For the right/test eye, a defocused image is projected onto the peripheral retina while the subject views a distant, in-focus image
Tabletop prototype of eSpecs: No Active projection of defocused image in the peripheral visual fieldDevice
For the left/control eye, no image is projected onto the peripheral retina. The subject views a distant, in-focus image.

Study groups in NCT04388020
Study group	Role	What they receive
Test Arm	Experimental	Not described Receives: Device: Tabletop prototype of eSpecs: Active projection of defocused image in the peripheral visual field; Device: Tabletop prototype of eSpecs: No Active projection of defocused image in the peripheral visual field

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.

11 Apr 202014 May 2020

First posted14 May 2020
Study start11 Apr 2020
Primary completion14 May 2020
Study completion14 May 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: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04388020
Sponsor's protocol ID: eSpec Phase IIB
Status last verified: May 2021
First submitted: 7 May 2020
Last updated: 21 May 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Projected Peripheral Defocus on Ocular Biometrics
ClinicalTrials.gov ID: NCT04388020
Acronym / sponsor ID: eSpec Phase IIB
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Kubota Vision Inc.Industry (pharma, biotech, devices)
Study start: 11 Apr 2020 (actual)
Primary completion: 14 May 2020 (actual)
Study completion: 14 May 2020 (actual)
First posted: 14 May 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.

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: Tabletop prototype of eSpecs: Active projection of defocused image in the peripheral visual field, Device: Tabletop prototype of eSpecs: No Active projection of defocused image in the peripheral visual field

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
Tabletop prototype of eSpecs: Active projection of defocused image in the peripheral visual fieldFor 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
Tabletop prototype of eSpecs: No Active projection of defocused image in the peripheral visual fieldFor 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 21 May 2021.
Individual participant dataSharing planned: No

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 21 May 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?

On the ClinicalTrials.gov record for NCT04388020.

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 21 May 2021.