MyopiaNCT06812572
A Prospective Clinical Study to Evaluate the Repeatability of the Visibly Vision Test
A study testing Visibly Vision Test in people with Myopia and Astigmatism, run by Visibly at 1 site in United States.
Trial summary
The study is a prospective, multi-center, single-arm, non-randomized, non-blinded, observational study to evaluate the test-retest reliability of the Visibly Vision Test. Additionally, observational data will be collected to understand whether the subject performs the set-up process correctly and subject comprehension… Read more about this study
- Who is it for?
- Ages 22 to 55 years
- Conditions the study is for
- Myopia, Astigmatism
- What is being tested?
- Visibly Vision Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2019to 25 Mar 2019
- 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 22 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female, age 22 to 55 years at the time of consent;Recent (within 24 months) in-person comprehensive eye examination with a licensed eyecare professional and have prior prescription values (sphere, cylinder, axis) available;Subject must have either documented recent refractive error not greater than -1.00D of myopia and no greater than -2.00D astigmatism in either eye or documented prior correction no greater than -6.00D of myopia in either eye. Subject are without known existing eye disease or history of systemic disease that may affect the eye; Subjects with known BCVA of 20/32 or better per recent prescription
Who cannot join
- Subject has had prior use of the Visibly Vision Test; Subjects with known diabetes mellitus; Subjects using ophthalmic or systemic corticosteroids; Subjects with known autoimmune conditions (e.g. Grave's disease, rheumatoid arthritis); Subjects with active corneal or conjunctival infection;Subjects with active corneal, conjunctival, or intraocular inflammation (i.e., uveitis); Subjects with known diabetic retinopathy; Subjects with known glaucoma or ocular hypertension; Subjects with known macular degeneration; Subjects with previous ocular surgery; Subjects using antihyperglycemic agents; corticosteroids; hydroxychloroquine (Plaquenil) and chloroquine (Aralen); tamoxifen (Nolvadex); Subjects with a history of measured spherical difference between left and right eye of 4.00 D or greater;
Trial locations and contacts
1 site in 1 country.
About this study
The study is a prospective, multi-center, single-arm, non-randomized, non-blinded, observational study to evaluate the test-retest reliability of the Visibly Vision Test.
Additionally, observational data will be collected to understand whether the subject performs the set-up process correctly and subject comprehension of the patient labeling will also be evaluated.
Read the detailed description
Potentially eligible subjects who provide informed consent and are confirmed qualified will be presented a room simulating the home environment with, at minimum, a table; pair of internet-connected devices (if subject has not opted to use their own), as well as some common household items. Subjects will then be directed to visit the website clinical.opternative.com and follow instructions on the website to complete vision testing.
Following completion of the first test session, subjects will undergo a series of critical knowledge task questions administered by site staff to evaluate their understanding of the critical aspects of the proposed patient labeling. Subjects will not receive verbal feedback and the study staff will refrain from any non-verbal responses to the answers provided from the subjects.
At least four hours but not more than 72 hours from the completion of the first test, each subject will be asked to return to the testing room, and complete the Visibly Vision Test again, including repeating the on-boarding, set-up, test, and off-boarding processes.
Site staff will observe and document the second testing process in the same manner as for the subject's first test session.
Following completion of the second test (retest), subject participation will be considered complete.
- Conditions
- Myopia, Astigmatism
- Being tested
- Visibly Vision Test
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visibly Vision TestDevice
The Visibly Vision Test is used as a digital self-administered device to measure visual acuity and to subjectively measure refractive value for a patient's eye to determine the optical prescription for the conditions of myopia and astigmatism
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | Without using an available refractive correction and whose refractive error is no greater than -1.00D of myopia (spherical component in minus cylinder format) and with no greater than -2.00D of astigmatism in either eye Receives: Device: Visibly Vision Test |
| Cohort 2 | Other | With prior correction of no greater than -6.00D of myopia (spherical component in minus cylinder format) and require a spherical (non-astigmatic) over-refraction of no more than ±1.00 D in either eye Receives: Device: Visibly Vision Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test-retest variability (repeatability) of the Visibly Vision Test in the measurement of refractive error as assessed by the repeatability standard deviation using the Visibly software numerical outputs of estimated refractive error/correction.
The refractive error measurements will be those given by the Visibly software numerical outputs of estimated refractive error/correction.
For each component of the refractive error measured in diopters (sphere, cylinder, and spherical equivalent), the homogeneous repeatability will be assessed using repeated measurements within study eyes.
Measured: Retest conducted between four and 72 hours after initial test.
Secondary outcomes (1)
Collection of subject comprehension of critical aspects of patient labeling using subject response forms.
Collection of response from subjects regarding their comprehension of critical aspects of patient labeling.
Measured: Performed immediately after initial test completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start4 Mar 2019
- Primary completion25 Mar 2019
- Study completion25 Mar 2019
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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- multi-center, single-arm, non-randomized, non-blinded, interventional study
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Visibly
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812572
- Sponsor's protocol ID
- VVT-1002
- Status last verified
- Jan 2025
- First submitted
- 5 Mar 2019
- Last updated
- 6 Feb 2025
- 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 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study to Evaluate the Repeatability of the Visibly Vision Test
- ClinicalTrials.gov ID
- NCT06812572
- Acronym / sponsor ID
- VVT-1002
- Conditions
- Myopia, Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- VisiblyIndustry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 25 Mar 2019 (actual)
- First posted
- 6 Feb 2025 (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.
The study is a prospective, multi-center, single-arm, non-randomized, non-blinded, observational study to evaluate the test-retest reliability of the Visibly Vision Test.
Additionally, observational data will be collected to understand whether the subject performs the set-up process correctly and subject comprehension of the patient labeling will also be evaluated.
Detailed description
Potentially eligible subjects who provide informed consent and are confirmed qualified will be presented a room simulating the home environment with, at minimum, a table; pair of internet-connected devices (if subject has not opted to use their own), as well as some common household items. Subjects will then be directed to visit the website clinical.opternative.com and follow instructions on the website to complete vision testing.
Following completion of the first test session, subjects will undergo a series of critical knowledge task questions administered by site staff to evaluate their understanding of the critical aspects of the proposed patient labeling. Subjects will not receive verbal feedback and the study staff will refrain from any non-verbal responses to the answers provided from the subjects.
At least four hours but not more than 72 hours from the completion of the first test, each subject will be asked to return to the testing room, and complete the Visibly Vision Test again, including repeating the on-boarding, set-up, test, and off-boarding processes.
Site staff will observe and document the second testing process in the same manner as for the subject's first test session.
Following completion of the second test (retest), subject participation will be considered complete.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- multi-center, single-arm, non-randomized, non-blinded, interventional study
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Device: Visibly Vision TestWithout using an available refractive correction and whose refractive error is no greater than -1.00D of myopia (spherical component in minus cylinder format) and with no greater than -2.00D of astigmatism in either eye |
| Cohort 2 | Other | Device: Visibly Vision TestWith prior correction of no greater than -6.00D of myopia (spherical component in minus cylinder format) and require a spherical (non-astigmatic) over-refraction of no more than ±1.00 D in either eye |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male or female, age 22 to 55 years at the time of consent;Recent (within 24 months) in-person comprehensive eye examination with a licensed eyecare professional and have prior prescription values (sphere, cylinder, axis) available;Subject must have either documented recent refractive error not greater than -1.00D of myopia and no greater than -2.00D astigmatism in either eye or documented prior correction no greater than -6.00D of myopia in either eye. Subject are without known existing eye disease or history of systemic disease that may affect the eye; Subjects with known BCVA of 20/32 or better per recent prescription
Key exclusion criteria (1 listed)
- Subject has had prior use of the Visibly Vision Test; Subjects with known diabetes mellitus; Subjects using ophthalmic or systemic corticosteroids; Subjects with known autoimmune conditions (e.g. Grave's disease, rheumatoid arthritis); Subjects with active corneal or conjunctival infection;Subjects with active corneal, conjunctival, or intraocular inflammation (i.e., uveitis); Subjects with known diabetic retinopathy; Subjects with known glaucoma or ocular hypertension; Subjects with known macular degeneration; Subjects with previous ocular surgery; Subjects using antihyperglycemic agents; corticosteroids; hydroxychloroquine (Plaquenil) and chloroquine (Aralen); tamoxifen (Nolvadex); Subjects with a history of measured spherical difference between left and right eye of 4.00 D or greater;
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 |
|---|---|---|
| Visibly Vision TestThe Visibly Vision Test is used as a digital self-administered device to measure visual acuity and to subjectively measure refractive value for a patient's eye to determine the optical prescription for the conditions of myopia and astigmatism | Device | Cohort 1, Cohort 2 |
Primary outcome
Test-retest variability (repeatability) of the Visibly Vision Test in the measurement of refractive error as assessed by the repeatability standard deviation using the Visibly software numerical outputs of estimated refractive error/correction.
Time frame: Retest conducted between four and 72 hours after initial test.
The refractive error measurements will be those given by the Visibly software numerical outputs of estimated refractive error/correction. For each component of the refractive error measured in diopters (sphere, cylinder, and spherical equivalent), the homogeneous repeatability will be assessed using repeated measurements within study eyes.
1 secondary outcome
Collection of subject comprehension of critical aspects of patient labeling using subject response forms.
Time frame: Performed immediately after initial test completion
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 6 Feb 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visibly Vision Test in people with Myopia and Astigmatism, run by Visibly 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 1 inclusion and 1 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 6 Feb 2025. 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?
Test-retest variability (repeatability) of the Visibly Vision Test in the measurement of refractive error as assessed by the repeatability standard deviation using the Visibly software numerical outputs of estimated refractive error/correction. (time frame: Retest conducted between four and 72 hours after initial test.). 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 6 Feb 2025.