Study of Retinal Vascular Changes After Ocular Blunt Trauma

Ocular Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04546997
• Other study ID #: 1212/2019
• Status: Completed
• Start date: January 10, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: September 2020
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 30, 2019
• Est. primary completion date: December 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ocular Injury
• Wounds, Nonpenetrating

Intervention

Diagnostic Test:
• Optical Coherence Tomography Angiography
Patients underwent non-invasive, fast, diagnostic imaging technique (optical coherence tomography angiography)

Locations

Country	Name	City	State
Italy	University of Naples "Federico II"	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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