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Completed

NCT Number: NCT04546997

Study of Retinal Vascular Changes After Ocular Blunt Trauma

This study evaluates the retinal vascular features using optical coherence tomography angiography in patients that received ocular blunt trauma.

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Key information

Conditions

Ocular Injury Craniocerebral Trauma Eye Diseases Eye Injuries Facial Injuries Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Naples "Federico II"

Naples, 80100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Optical Coherence tomography angiography

Diagnostic Test

Patients underwent non-invasive, fast, diagnostic imaging technique (optical coherence tomography angiography)

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Retinal Vascular Features in Ocular Blunt Trauma by Optical Coherence Tomography Angiography

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 14, 2020
Registry last updated
Sep 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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