AccommodationNCT03957408
Investigational Study of Accommodation Triggering and Control to Allow for the Performance of Refraction Measurements
A study testing Visual Stimuli in people with Accommodation, run by EyeQue Corp. at 1 site in United States.
Trial summary
An investigational study in the control of the user's accommodative state via visual stimuli. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Accommodation
- What is being tested?
- Visual Stimuli
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2019to 18 Dec 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or Female
- Age 18 through 30 years at the time of consent
- Binocular vision
- Willing and able to give informed consent and follow all study procedures and requirements
- Fluent in English
Who cannot join
- Spherical correction > +4D or < -5D, astigmatism < -2.5D.
- Using anticholinergic medications (including first-generation antihistamines) or other medications known to affect visual acuity within the greater of 3 days or 5 half-lives prior to enrolling in this study
- Using an investigational drug or approved therapy for investigational use within the greater of 3 days or 5 half-lives prior to enrolling in this study
- Has initiated any new medication in the past 2 weeks that, in the best medical judgment of the investigator, would impact their participation in the study or ability to use EyeQue devices
- Reported or observed eye disease or pathology, including but not limited to:
- Glaucoma
Show all 23Show fewer
- Cataracts
- Macular degeneration
- Eye infection
- Keratoconus
- Diabetic neuropathy/retinopathy
- Cytomegalovirus retinitis
- Color blindness (any color deficiency)
- Diabetic macular edema
- Amblyopia
- Chronic or acute uveitis (cells and/or flare in anterior chamber)
- Strabismus (exotropia, esotropia, and hypertropia)
- Macular hole
- Eye surgery within the last 12 months (including Lasik or lens replacement)
- Subject does not have the physical dexterity to properly operate the EyeQue VisionCheck device or the EyeQue app on the smartphone in the investigator's opinion
- PD smaller than 50mm or larger than 75mm.
- Any self-reported mental illness or condition, including but not limited to: claustrophobia, fear of simulators, nyctophobia.
- Any self-reported neurological diseases, including but not limited to: epilepsy, Alzheimer's, nystagmus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigational Study of Accommodation Triggering and Control to Allow for the Performance of Refraction Measurements
An investigational study in the control of the user's accommodative state via visual stimuli.
Read the detailed description
The EyeQue Corporation (EyeQue) is developing devices to measure refraction that can be used outside of the clinic. The refraction devices require the user to perform a series of tests while looking through it to view a visual display. The current devices do not currently account for accommodation and therefore may present inaccurate results for the younger population where the accommodation effect is quite significant. This study is aimed at enabling future EyeQue refraction measurement products to overcome this issue and provide the required tools to allow for accommodation measurement, correction and control. Control of the user's accommodative state will allow for measurement of near vision as well as far vision based on the refractive measurement.
- Conditions
- Accommodation
- Being tested
- Visual Stimuli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual StimuliDevice
Subjects will be presented various visual stimuli and may be asked to perform tasks. Their accommodative response will be measured.
| Study group | Role | What they receive |
|---|---|---|
| Visual Stimuli | Experimental | Participants will be presented various visual stimuli in which accommodative response is measured. Receives: Device: Visual Stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accommodative Response
Measurement of accommodative response by measuring visual refraction while the subject is viewing various visual stimuli.
Measured: Through study completion, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start3 Sep 2019
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AccommodationStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyeQue Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Noam Sapiens, Principal investigator, EyeQue Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957408
- Sponsor's protocol ID
- EYEQUE - 002
- Status last verified
- Jan 2020
- First submitted
- 9 May 2019
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigational Study of Accommodation Triggering and Control to Allow for the Performance of Refraction Measurements
- ClinicalTrials.gov ID
- NCT03957408
- Acronym / sponsor ID
- EYEQUE - 002
- Conditions
- Accommodation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- EyeQue Corp.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 21 May 2019 (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.
An investigational study in the control of the user's accommodative state via visual stimuli.
Detailed description
The EyeQue Corporation (EyeQue) is developing devices to measure refraction that can be used outside of the clinic. The refraction devices require the user to perform a series of tests while looking through it to view a visual display. The current devices do not currently account for accommodation and therefore may present inaccurate results for the younger population where the accommodation effect is quite significant. This study is aimed at enabling future EyeQue refraction measurement products to overcome this issue and provide the required tools to allow for accommodation measurement, correction and control. Control of the user's accommodative state will allow for measurement of near vision as well as far vision based on the refractive measurement.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Visual Stimuli | Experimental | Device: Visual StimuliParticipants will be presented various visual stimuli in which accommodative response is measured. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or Female
- Age 18 through 30 years at the time of consent
- Binocular vision
- Willing and able to give informed consent and follow all study procedures and requirements
- Fluent in English
Key exclusion criteria (23 listed)
- Spherical correction > +4D or < -5D, astigmatism < -2.5D.
- Using anticholinergic medications (including first-generation antihistamines) or other medications known to affect visual acuity within the greater of 3 days or 5 half-lives prior to enrolling in this study
- Using an investigational drug or approved therapy for investigational use within the greater of 3 days or 5 half-lives prior to enrolling in this study
- Has initiated any new medication in the past 2 weeks that, in the best medical judgment of the investigator, would impact their participation in the study or ability to use EyeQue devices
- Reported or observed eye disease or pathology, including but not limited to:
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 |
|---|---|---|
| Visual StimuliSubjects will be presented various visual stimuli and may be asked to perform tasks. Their accommodative response will be measured. | Device | Visual Stimuli |
Primary outcome
Accommodative Response
Time frame: Through study completion, an average of 5 months
Measurement of accommodative response by measuring visual refraction while the subject is viewing various visual stimuli.
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 24 Mar 2021.
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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.
Noam Sapiens principal investigator
EyeQue Corp.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Stimuli in people with Accommodation, run by EyeQue Corp. 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 5 inclusion and 23 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 24 Mar 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?
Accommodative Response (time frame: Through study completion, an average of 5 months). 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 24 Mar 2021.