Eyes Without Ocular PathologyNCT03887104
Data Collection of OCT and OCTA-based Ocular Measurements
An observational study of Eyes Without Ocular Pathology, run by Optovue at 5 sites in United States.
Trial summary
Data Collection of OCT and OCTA-based Ocular Measurements Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eyes Without Ocular Pathology
- What is being tested?
- SD-OCT
- Type of treatment
- Medical device
- How many people
- 482 participants
- Where
- 5 sitesUnited States
- Study dates
- 8 Feb 2019to 30 Aug 2019
- 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 Any age
- Child, Adult, Older adult
Study population: Persons having eyes without ocular pathology
Who may be able to join
- No glaucoma
- No retinal pathology
- No systemic disorders impacting the eye
- No ocular surgery or medical treatment of ocular condition
Who cannot join
- High IOP
- Poor vision
- Clinical findings consistent with pathology
- Unable to complete the study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Eye Care Institute
Fort Lauderdale, Florida, 33312
AMA Eye Physicians & Surgeons
Marysville, Ohio, 43040
IOVS
Newark, New Jersey, 07103
Eye Care Center
Pomona, California, 91766
College of Optometry
Tahlequah, Oklahoma, 74464
About this study
Data Collection of OCT and OCTA-based Ocular Measurements
Read the detailed description
The purpose of this study is to collect measurements of anatomical structures of the posterior pole of the eye based on OCT scans in subjects without clinical signs of pathology.
- Conditions
- Eyes Without Ocular Pathology
- Being tested
- SD-OCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SD-OCTDevice
Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal thickness
micrometers
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 posted22 Mar 2019
- Study start8 Feb 2019
- Primary completion11 Jul 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eyes Without Ocular PathologyStudies 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
- 482 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optovue
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887104
- Sponsor's protocol ID
- 200-53771
- Status last verified
- Aug 2019
- First submitted
- 11 Mar 2019
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection of OCT and OCTA-based Ocular Measurements
- ClinicalTrials.gov ID
- NCT03887104
- Acronym / sponsor ID
- 200-53771
- Conditions
- Eyes Without Ocular Pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 482 participants (actual)
- Lead sponsor
- OptovueIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 11 Jul 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 22 Mar 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.
Data Collection of OCT and OCTA-based Ocular Measurements
Detailed description
The purpose of this study is to collect measurements of anatomical structures of the posterior pole of the eye based on OCT scans in subjects without clinical signs of pathology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Persons having eyes without ocular pathology
Key inclusion criteria (4 listed)
- No glaucoma
- No retinal pathology
- No systemic disorders impacting the eye
- No ocular surgery or medical treatment of ocular condition
Key exclusion criteria (4 listed)
- High IOP
- Poor vision
- Clinical findings consistent with pathology
- Unable to complete the study
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 |
|---|---|---|
| SD-OCTSpectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures | Device | – |
Primary outcome
Retinal thickness
Time frame: Day 1
micrometers
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 3 Sep 2019.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eyes Without Ocular Pathology, run by Optovue at 5 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 4 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 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Retinal thickness (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 3 Sep 2019.