Normal Eyes and Eyes With Ocular PathologiesNCT03852485
Comparison of OCT and OCTA-based Ocular Measurements to Those of Predicate
An observational study of Normal Eyes and Eyes With Ocular Pathologies, run by Optovue at 2 sites in United States.
Trial summary
Comparison of OCT and OCTA-based Ocular Measurements to those of Predicate Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Eyes and Eyes With Ocular Pathologies
- What is being tested?
- SD-OCT
- Type of treatment
- Medical device
- How many people
- 199 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Jan 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Seeing eye doctor for routine care
Who may be able to join
None listed.
Who cannot join
- Normal - Unable to complete required exams; Clinical finding of posterior pathology or VA worse than 20/40 for posterior imaging; Clinical findings of corneal condition for corneal imaging.
- Glaucoma - Unable to complete required exams; Clinical signs of retinal pathology.
- Retina - Unable to complete required exams.
- Cornea - Unable to complete required exams.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
AMA
Marysville, Ohio, 43040
IOVS
Newark, New Jersey, 07103
About this study
Comparison of OCT and OCTA-based Ocular Measurements to those of Predicate
Read the detailed description
The purpose of this study is to compare with predicate device for the measurements of vascular structures and anatomical structures of the posterior pole of the eye based on OCTA and OCT scans in normal subjects, glaucoma patients, and retina patients, and to compare with predicate device for the measurements of corneal layers based on corneal OCT scans in normal subjects and cornea patients.
- 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
| Study group | Role | What they receive |
|---|---|---|
| Normal | no glaucoma or retinal pathology or corneal conditions Receives: Device: SD-OCT | |
| Glaucoma | diagnosis of glaucoma Receives: Device: SD-OCT | |
| Retina | diagnosis of AMD, DR or other retinal pathology Receives: Device: SD-OCT | |
| Cornea | wear contact lens or prior refractive surgery or having dry eye or KCN Receives: Device: SD-OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limits of agreement
estimation of the interval within which a proportion of the differences between measurements lie
Measured: Day 1
Secondary outcomes (1)
Regression Analysis
statistical process for estimating the relationships among variables
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 posted25 Feb 2019
- Study start29 Jan 2019
- Primary completion2 Aug 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 Normal Eyes and Eyes With Ocular PathologiesStudies 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
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optovue
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852485
- Sponsor's protocol ID
- 200-53769
- Status last verified
- Aug 2019
- First submitted
- 21 Feb 2019
- Last updated
- 3 Sep 2019
- 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 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of OCT and OCTA-based Ocular Measurements to Those of Predicate
- ClinicalTrials.gov ID
- NCT03852485
- Acronym / sponsor ID
- 200-53769
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- OptovueIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 25 Feb 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.
Comparison of OCT and OCTA-based Ocular Measurements to those of Predicate
Detailed description
The purpose of this study is to compare with predicate device for the measurements of vascular structures and anatomical structures of the posterior pole of the eye based on OCTA and OCT scans in normal subjects, glaucoma patients, and retina patients, and to compare with predicate device for the measurements of corneal layers based on corneal OCT scans in normal subjects and cornea patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal | – | Device: SD-OCTno glaucoma or retinal pathology or corneal conditions |
| Glaucoma | – | Device: SD-OCTdiagnosis of glaucoma |
| Retina | – | Device: SD-OCTdiagnosis of AMD, DR or other retinal pathology |
| Cornea | – | Device: SD-OCTwear contact lens or prior refractive surgery or having dry eye or KCN |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Seeing eye doctor for routine care
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Normal - Unable to complete required exams; Clinical finding of posterior pathology or VA worse than 20/40 for posterior imaging; Clinical findings of corneal condition for corneal imaging.
- Glaucoma - Unable to complete required exams; Clinical signs of retinal pathology.
- Retina - Unable to complete required exams.
- Cornea - Unable to complete required exams.
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 | Cornea, Glaucoma, Normal, Retina |
Primary outcome
Limits of agreement
Time frame: Day 1
estimation of the interval within which a proportion of the differences between measurements lie
1 secondary outcome
Regression Analysis
Time frame: Day 1
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.
- 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.
2 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 and Eyes With Ocular Pathologies, run by Optovue at 2 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 0 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 2 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?
Limits of agreement (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.