Visual ImpairmentNCT04820218
At-home Testing Refraction Results With Best Corrected Visual Acuity (BCVA) Outcomes in Adults
A study testing With Try-on glasses in people with Visual Impairment and Myopia, run by EyeQue Corp. at 1 site in United States.
Trial summary
This study is aimed at examining the BCVA from try-on glasses constructed from measurements from the EyeQue VisionCheck. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Visual Impairment, Myopia, Hyperopia
- What is being tested?
- With Try-on glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2021to 20 Jan 2023
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female
- Ages 30+
- Had purchased an EyeQue refraction device.
- Obtained EGN's from the EyeQue refraction device.
- Ordered Try-On glasses based on EyeQue EyeGlass Numbers.
- Allow use for this study the VisionCheck refraction and try-on glasses measurements, taken prior to study participation.
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- Subject Exclusion Criteria, Subjects that by self-report:
- Do not have a command of the English language.
- Lack the ability to follow instructions.
- Lack binocular vision.
- Are Color-blind.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Study to Evaluate At-home Testing Refraction Results With Best Corrected Visual Acuity (BCVA) Outcomes in Adults
This study is aimed at examining the BCVA from try-on glasses constructed from measurements from the EyeQue VisionCheck.
Read the detailed description
This study is aimed at examining the BCVA from try-on glasses constructed from measurements from the EyeQue VisionCheck. The refraction measurements that users obtain from the VisionCheck are from testing at-home and without additional guidance other than that normally provided to those purchasing the device.
- Conditions
- Visual Impairment, Myopia, Hyperopia, Astigmatism
- Being tested
- With Try-on glasses
- Medical subject headings
- Vision Disorders, Myopia, Hyperopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With Try-on glassesDevice
Subjects will be asked to measure their visual acuity with their try-on glasses
| Study group | Role | What they receive |
|---|---|---|
| Without Try-on glasses | Other | Subjects will be asked to measure their visual acuity without their try-on glasses Receives: Device: With Try-on glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity with and without try-on glasses
Visual Acuity with and without try-on glasses
Measured: Visit 1: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start21 Apr 2021
- Primary completion20 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual ImpairmentStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects who had previously tested with an EyeQue ophthalmic refraction device and ordered try-on glasses will be asked to measure their visual acuity with and without their try-on glasses.
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyeQue Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Noam Sapiens, PhD, Principal investigator, EyeQue Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820218
- Sponsor's protocol ID
- EYEQUE - 008
- Status last verified
- Jan 2023
- First submitted
- 23 Mar 2021
- Last updated
- 25 Jan 2023
- 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 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Evaluate At-home Testing Refraction Results With Best Corrected Visual Acuity (BCVA) Outcomes in Adults
- ClinicalTrials.gov ID
- NCT04820218
- Acronym / sponsor ID
- EYEQUE - 008
- Conditions
- Visual Impairment, Myopia, Hyperopia, Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- EyeQue Corp.Industry (pharma, biotech, devices)
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 29 Mar 2021 (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.
This study is aimed at examining the BCVA from try-on glasses constructed from measurements from the EyeQue VisionCheck.
Detailed description
This study is aimed at examining the BCVA from try-on glasses constructed from measurements from the EyeQue VisionCheck. The refraction measurements that users obtain from the VisionCheck are from testing at-home and without additional guidance other than that normally provided to those purchasing the device.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects who had previously tested with an EyeQue ophthalmic refraction device and ordered try-on glasses will be asked to measure their visual acuity with and without their try-on glasses.
| Arm | Type | Receives |
|---|---|---|
| Without Try-on glasses | Other | Device: With Try-on glassesSubjects will be asked to measure their visual acuity without their try-on glasses |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or Female
- Ages 30+
- Had purchased an EyeQue refraction device.
- Obtained EGN's from the EyeQue refraction device.
- Ordered Try-On glasses based on EyeQue EyeGlass Numbers.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| With Try-on glassesSubjects will be asked to measure their visual acuity with their try-on glasses | Device | Without Try-on glasses |
Primary outcome
Visual Acuity with and without try-on glasses
Time frame: Visit 1: Day 0
Visual Acuity with and without try-on glasses
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 25 Jan 2023.
- 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.
Noam Sapiens, PhD principal investigator
EyeQue Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing With Try-on glasses in people with Visual Impairment and Myopia, 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 11 inclusion and 0 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 25 Jan 2023. 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?
Visual Acuity with and without try-on glasses (time frame: Visit 1: Day 0). 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 25 Jan 2023; AzTrials last refreshed its copy on 30 Oct 2026.