Study of Retinal Vascular Changes After Ocular Blunt Trauma

September 6, 2020 updated by: Gilda Cennamo, Federico II University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80100
        • University of Naples "Federico II"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The participans were older than 40 years with diagnosis of previous ocular blunt trauma. They did not present other ophthalmological diseases.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control Group
Healthy fellow eyes without actual and previous ocular trauma
Diagnostic test: Optical Coherence Tomography Angiography
Patients underwent non-invasive, fast, diagnostic imaging technique (optical coherence tomography angiography)
Patients with ocular blunt trauma
Patients with previous ocular blunt trauma in one eye.
Diagnostic test: Optical Coherence Tomography Angiography
Patients underwent non-invasive, fast, diagnostic imaging technique (optical coherence tomography angiography)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Investigators

  • Principal Investigator: Gilda Cennamo, MD, Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2019

Primary Completion (Actual)

December 25, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

September 6, 2020

First Submitted That Met QC Criteria

September 6, 2020

First Posted (Actual)

September 14, 2020

Study Record Updates

Last Update Posted (Actual)

September 14, 2020

Last Update Submitted That Met QC Criteria

September 6, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1212/2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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