Normal Eyes and Ocular PathologyOCTNCT04437082
Performance Evaluation of OCT and OCT Angiography-based Ocular Measurements (Optical Coherence Tomography)
An observational study of Normal Eyes and Ocular Pathology, run by Optovue at 1 site in United States.
Trial summary
The purpose of this study is to assess performance of measurements of anatomical and vascular structures of the eye based on OCT and OCTA scans in normal subjects and eyes with pathology. 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 Ocular Pathology
- What is being tested?
- optical coherence tomography
- Type of treatment
- Medical device
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2021to 30 Apr 2021
- 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 - No pre-existing conditions.
- Glaucoma - Diagnosis of glaucoma.
- Retina - Diagnosis of retinal pathology
- Cornea - Diagnosis of clinic condition.
Who cannot join
- Unable to complete required exams.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma College of Optometry, Northeastern State University
Tahlequah, Oklahoma, 74464
About this study
Official title: Performance Evaluation of OCT and OCTA-based Ocular Measurements
The purpose of this study is to assess performance of measurements of anatomical and vascular structures of the eye based on OCT and OCTA scans in normal subjects and eyes with pathology.
- Conditions
- Normal Eyes and Ocular Pathology
- Being tested
- optical coherence tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optical coherence tomographyDevice
imaging structural and vascular features of the eye
| Study group | Role | What they receive |
|---|---|---|
| Normal | no pre-existing conditions Receives: Device: optical coherence tomography | |
| Glaucoma | diagnosis of glaucoma Receives: Device: optical coherence tomography | |
| Retina | diagnosis of retina pathology Receives: Device: optical coherence tomography | |
| Cornea | diagnosis of corneal condition Receives: Device: optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard Deviation
measure of variance
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 posted18 Jun 2020
- Study start15 Jan 2021
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Eyes and 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
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optovue
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437082
- Sponsor's protocol ID
- 200-54611
- Acronym
- OCT
- Status last verified
- Feb 2021
- First submitted
- 15 Jun 2020
- Last updated
- 20 Sep 2021
- 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 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of OCT and OCTA-based Ocular Measurements
- ClinicalTrials.gov ID
- NCT04437082
- Acronym / sponsor ID
- OCT / 200-54611
- Conditions
- Normal Eyes and Ocular Pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- OptovueIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 18 Jun 2020 (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 purpose of this study is to assess performance of measurements of anatomical and vascular structures of the eye based on OCT and OCTA scans in normal subjects and eyes with pathology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal | – | Device: optical coherence tomographyno pre-existing conditions |
| Glaucoma | – | Device: optical coherence tomographydiagnosis of glaucoma |
| Retina | – | Device: optical coherence tomographydiagnosis of retina pathology |
| Cornea | – | Device: optical coherence tomographydiagnosis of corneal condition |
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 (4 listed)
- Normal - No pre-existing conditions.
- Glaucoma - Diagnosis of glaucoma.
- Retina - Diagnosis of retinal pathology
- Cornea - Diagnosis of clinic condition.
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| optical coherence tomographyimaging structural and vascular features of the eye | Device | Cornea, Glaucoma, Normal, Retina |
Primary outcome
Standard Deviation
Time frame: Day 1
measure of variance
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 Sep 2021.
- 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?
An observational study of Normal Eyes and Ocular Pathology, run by Optovue 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 4 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 20 Sep 2021. 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?
Standard 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 20 Sep 2021.