Normal, Glaucoma & Retinal PathologyNCT02911883
Evaluation of the Repeatability and Reproducibility of AngioVue
An observational study of Normal, Glaucoma & Retinal Pathology, run by Optovue.
Trial summary
The purpose of this study is to assess the repeatability and reproducibility of measurements of the vascular structures and the anatomical structures of the posterior pole of the eye based on AngioVue volume scans in normal subjects, glaucoma patients, and retina patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal, Glaucoma & Retinal Pathology
- What is being tested?
- Optical Coherence Tomography Angiography
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 29 Aug 2016to 2 Feb 2017
- 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 or follow-up care
Who may be able to join
- Normal
- Age > 18.
- No retinal pathology or glaucoma.
- Glaucoma patient
- Age > 18.
- Have glaucoma.
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- Retina patient
- Age > 18.
- Have retina pathology.
Who cannot join
- Normal
- Unable to complete required exams.
- Poor quality image data.
- Glaucoma patient
- Unable to complete required exams.
- Poor quality image data.
Show all 11Show fewer
- Retinal pathology.
- Retina patient
- Unable to complete required exams.
- Poor quality image data.
- Glaucoma.
About this study
The purpose of this study is to assess the repeatability and reproducibility of measurements of the vascular structures and the anatomical structures of the posterior pole of the eye based on AngioVue volume scans in normal subjects, glaucoma patients, and retina patients.
- Conditions
- Normal, Glaucoma & Retinal Pathology
- Being tested
- Optical Coherence Tomography Angiography
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography AngiographyDevice
| Study group | Role | What they receive |
|---|---|---|
| Normal | Not having glaucoma or retinal pathology Receives: Device: Optical Coherence Tomography Angiography | |
| Glaucoma | Having glaucoma. Receives: Device: Optical Coherence Tomography Angiography | |
| Retina | Having retinal pathology Receives: Device: Optical Coherence Tomography Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retina vasculature
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 Sep 2016 (estimated)
- Study start29 Aug 2016
- Primary completion1 Feb 2017
- Study completion2 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal, Glaucoma & Retinal 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optovue
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911883
- Sponsor's protocol ID
- 200-51133
- Status last verified
- Jun 2017
- First submitted
- 20 Sep 2016
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Repeatability and Reproducibility of AngioVue
- ClinicalTrials.gov ID
- NCT02911883
- Acronym / sponsor ID
- 200-51133
- Conditions
- Normal, Glaucoma & Retinal Pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- OptovueIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2016 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 2 Feb 2017 (actual)
- First posted
- 22 Sep 2016 (estimated)
- 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 purpose of this study is to assess the repeatability and reproducibility of measurements of the vascular structures and the anatomical structures of the posterior pole of the eye based on AngioVue volume scans in normal subjects, glaucoma patients, and retina patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal | – | Device: Optical Coherence Tomography AngiographyNot having glaucoma or retinal pathology |
| Glaucoma | – | Device: Optical Coherence Tomography AngiographyHaving glaucoma. |
| Retina | – | Device: Optical Coherence Tomography AngiographyHaving retinal pathology |
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 or follow-up care
Key inclusion criteria (9 listed)
- Normal
- Glaucoma patient
- Retina patient
Key exclusion criteria (11 listed)
- Normal
- Glaucoma patient
- Retina patient
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 |
|---|---|---|
| Optical Coherence Tomography Angiography | Device | Glaucoma, Normal, Retina |
Primary outcome
Retina vasculature
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 20 Jun 2017.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal, Glaucoma & Retinal Pathology, run by Optovue.
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 9 inclusion and 11 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 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Retina vasculature (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 20 Jun 2017.