Ocular InjuryNCT04546997
Study of Retinal Vascular Changes After Ocular Blunt Trauma
An observational study of Ocular Injury, run by Federico II University at 1 site in Italy.
Trial summary
This study evaluates the retinal vascular features using optical coherence tomography angiography in patients that received ocular blunt trauma. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ocular Injury
- What is being tested?
- Optical Coherence Tomography Angiography
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2019to 30 Dec 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The participans were older than 40 years with diagnosis of previous ocular blunt trauma. They did not present other ophthalmological diseases.
Who may be able to join
- age older than 40 years
- diagnosis of previous ocular blunt trauma
- absence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
- absence of significant lens opacities, low-quality OCT and OCT-A images.
Who cannot join
- age younger than 40 years
- absence of previous ocular blunt trauma
- presence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
- presence of significant lens opacities, low-quality OCT and OCT-A images.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retinal Vascular Features in Ocular Blunt Trauma by Optical Coherence Tomography Angiography
This study evaluates the retinal vascular features using optical coherence tomography angiography in patients that received ocular blunt trauma.
Read the detailed description
To investigate, using optical coherence tomography angiography, early retinal vascular features 48 hours after ocular trauma and to detect their changes during 6 months' follow up.
The optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed analysis of retinal vascular features.
- Conditions
- Ocular Injury
- Being tested
- Optical Coherence Tomography Angiography
- Medical subject headings
- Eye Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography AngiographyDiagnostic test
Patients underwent non-invasive, fast, diagnostic imaging technique (optical coherence tomography angiography)
| Study group | Role | What they receive |
|---|---|---|
| Patients with ocular blunt trauma | Patients with previous ocular blunt trauma in one eye. Receives: Diagnostic Test: Optical Coherence Tomography Angiography | |
| Control Group | Healthy fellow eyes without actual and previous ocular trauma Receives: Diagnostic Test: Optical Coherence Tomography Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measurements of retinal vessel density in patients after ocular blunt trauma during 6 months's follow up
To evaluate the changes in retinal vessel density in 18 patients, at baseline and 1, 3, 6 months after ocular blunt trauma, using optical coherence tomography angiography.
The parameter analyzed by optical coherence tomography angiography was: retinal vessel density
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start10 Jan 2019
- Primary completion25 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular InjuryStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilda Cennamo, Federico II University
- Investigators
- Gilda Cennamo, MD, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546997
- Sponsor's protocol ID
- 1212/2019
- Status last verified
- Sep 2020
- First submitted
- 6 Sep 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Vascular Features in Ocular Blunt Trauma by Optical Coherence Tomography Angiography
- ClinicalTrials.gov ID
- NCT04546997
- Acronym / sponsor ID
- 1212/2019
- Conditions
- Ocular Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 25 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 14 Sep 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.
This study evaluates the retinal vascular features using optical coherence tomography angiography in patients that received ocular blunt trauma.
Detailed description
To investigate, using optical coherence tomography angiography, early retinal vascular features 48 hours after ocular trauma and to detect their changes during 6 months' follow up.
The optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed analysis of retinal vascular features.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with ocular blunt trauma | – | Diagnostic Test: Optical Coherence Tomography AngiographyPatients with previous ocular blunt trauma in one eye. |
| Control Group | – | Diagnostic Test: Optical Coherence Tomography AngiographyHealthy fellow eyes without actual and previous ocular trauma |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The participans were older than 40 years with diagnosis of previous ocular blunt trauma. They did not present other ophthalmological diseases.
Key inclusion criteria (4 listed)
- age older than 40 years
- diagnosis of previous ocular blunt trauma
- absence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
- absence of significant lens opacities, low-quality OCT and OCT-A images.
Key exclusion criteria (4 listed)
- age younger than 40 years
- absence of previous ocular blunt trauma
- presence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
- presence of significant lens opacities, low-quality OCT and OCT-A images.
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 AngiographyPatients underwent non-invasive, fast, diagnostic imaging technique (optical coherence tomography angiography) | Diagnostic test | Control Group, Patients with ocular blunt trauma |
Primary outcome
The measurements of retinal vessel density in patients after ocular blunt trauma during 6 months's follow up
Time frame: Six months
To evaluate the changes in retinal vessel density in 18 patients, at baseline and 1, 3, 6 months after ocular blunt trauma, using optical coherence tomography angiography. The parameter analyzed by optical coherence tomography angiography was: retinal vessel density
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 14 Sep 2020.
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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.
Gilda Cennamo, MD principal investigator
Federico II University
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 Ocular Injury, run by Federico II University at 1 site in Italy.
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 14 Sep 2020. 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 Italy. 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?
The measurements of retinal vessel density in patients after ocular blunt trauma during 6 months's follow up (time frame: Six months). 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 14 Sep 2020.