Study of Retinal Vascular Changes After Ocular Blunt Trauma
Retinal Vascular Features in Ocular Blunt Trauma by Optical Coherence Tomography Angiography
1 other identifier
observational
18
1 country
1
Brief Summary
This study evaluates the retinal vascular features using optical coherence tomography angiography in patients that received ocular blunt trauma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedFirst Submitted
Initial submission to the registry
September 6, 2020
CompletedFirst Posted
Study publicly available on registry
September 14, 2020
CompletedSeptember 14, 2020
September 1, 2020
12 months
September 6, 2020
September 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Six months
Study Arms (2)
Patients with ocular blunt trauma
Patients with previous ocular blunt trauma in one eye.
Control Group
Healthy fellow eyes without actual and previous ocular trauma
Interventions
Patients underwent non-invasive, fast, diagnostic imaging technique (optical coherence tomography angiography)
Eligibility Criteria
The participans were older than 40 years with diagnosis of previous ocular blunt trauma. They did not present other ophthalmological diseases.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Naples "Federico II"
Naples, 80100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gilda Cennamo, MD
Federico II University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 6, 2020
First Posted
September 14, 2020
Study Start
January 10, 2019
Primary Completion
December 25, 2019
Study Completion
December 30, 2019
Last Updated
September 14, 2020
Record last verified: 2020-09