Normal EyesNCT05792046
IMOvifa Perimeter Reference Database
An observational study of Normal Eyes, run by New View Optometric Center at 4 sites in United States.
Trial summary
This study will collect data to establish a reference database for the IMOvifa perimeter. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Eyes
- What is being tested?
- Visual field
- Type of treatment
- Medical device
- How many people
- 376 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Mar 2023to 22 Sep 2023
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Persons with normal visual function
Who may be able to join
- 22 years of age or older on the date of informed consent
- Able to understand the written informed consent and willing to participate
- IOP ≤ 21 mmHg (each eye)
- BCVA 20/40 or better (each eye)
- Both eyes free of ocular conditions that may affect visual function (at doctor's discretion)
Who cannot join
- Unable to tolerate ophthalmic imaging and/or VF testing
- History of conditions known to adversely affect visual function (at doctor discretion)
- Spherical Equivalent refractive error outside the range from +6 Diopters
- Cylindrical refractive error outside the range +2.5 Diopters
Trial locations and contacts
4 sites in 1 country.
United States4 sites
New England College of Optometry
Boston, Massachusetts, 02115
Illinois College of Optometry
Chicago, Illinois, 60616
Topcon Healthcare Innovation Center
La Jolla, California, 92037
New View Optometric Center
La Mesa, California, 91942
About this study
This study will collect data to establish a reference database for the IMOvifa perimeter.
Read the detailed description
This study will collect data from a reference population to be used as inputs to the calculation of age corrected significance limits for expected visual function sensitivity to establish reference limits for key output parameters for select test patterns of the IMOvifa perimeter device.
- Conditions
- Normal Eyes
- Being tested
- Visual field
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual fieldDevice
test for detecting loss in visual function
| Study group | Role | What they receive |
|---|---|---|
| Normal | Subjects with normal visual function Receives: Device: Visual field |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reference limit for mean deviation
Visual sensitivity level in decibels
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start1 Mar 2023
- Primary completion4 Aug 2023
- Study completion22 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal EyesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- New View Optometric Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792046
- Sponsor's protocol ID
- NVOC-2023-02
- Status last verified
- Sep 2023
- First submitted
- 17 Mar 2023
- Last updated
- 29 Sep 2023
- 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 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMOvifa Perimeter Reference Database
- ClinicalTrials.gov ID
- NCT05792046
- Acronym / sponsor ID
- NVOC-2023-02
- Conditions
- Normal Eyes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- New View Optometric CenterIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 4 Aug 2023 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 30 Mar 2023 (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 will collect data to establish a reference database for the IMOvifa perimeter.
Detailed description
This study will collect data from a reference population to be used as inputs to the calculation of age corrected significance limits for expected visual function sensitivity to establish reference limits for key output parameters for select test patterns of the IMOvifa perimeter device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal | – | Device: Visual fieldSubjects with normal visual function |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with normal visual function
Key inclusion criteria (5 listed)
- 22 years of age or older on the date of informed consent
- Able to understand the written informed consent and willing to participate
- IOP ≤ 21 mmHg (each eye)
- BCVA 20/40 or better (each eye)
- Both eyes free of ocular conditions that may affect visual function (at doctor's discretion)
Key exclusion criteria (4 listed)
- Unable to tolerate ophthalmic imaging and/or VF testing
- History of conditions known to adversely affect visual function (at doctor discretion)
- Spherical Equivalent refractive error outside the range from +6 Diopters
- Cylindrical refractive error outside the range +2.5 Diopters
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 fieldtest for detecting loss in visual function | Device | Normal |
Primary outcome
Reference limit for mean deviation
Time frame: Day 1
Visual sensitivity level in decibels
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 29 Sep 2023.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Eyes, run by New View Optometric Center at 4 sites 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 4 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 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Reference limit for mean deviation (time frame: Day 1). 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 29 Sep 2023.