Study of Retinal Vascular Changes After Ocular Blunt Trauma

NCT ID: NCT04546997

Last Updated: 2020-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-10

Study Completion Date

2019-12-30

Brief Summary

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

Detailed Description

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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

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Ocular Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with ocular blunt trauma

Patients with previous ocular blunt trauma in one eye.

Optical Coherence Tomography Angiography

Intervention Type DIAGNOSTIC_TEST

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

Control Group

Healthy fellow eyes without actual and previous ocular trauma

Optical Coherence Tomography Angiography

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Optical Coherence Tomography Angiography

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Gilda Cennamo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gilda Cennamo, MD

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

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University of Naples "Federico II"

Naples, , Italy

Site Status

Countries

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Italy

Other Identifiers

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1212/2019

Identifier Type: -

Identifier Source: org_study_id

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