Study of Retinal Vascular Changes After Ocular Blunt Trauma

Completed

• Conditions: Ocular Injury
• Interventions: Diagnostic Test: Optical Coherence Tomography Angiography

• Registration Number: NCT04546997
• Lead Sponsor: Federico II University

Brief Summary

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

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 Timeline

• Study Start: 2019-01-10
• Primary Completion: 2019-12-25
• Study Completion: 2019-12-30
• Status Verified: 2020-09
• Study First Submitted: 2020-09-06
• Study First Submitted QC: 2020-09-06
• Last Update Submitted: 2020-09-06
• Study First Posted: 2020-09-14
• Last Update Posted: 2020-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group	Optical Coherence Tomography Angiography	Healthy fellow eyes without actual and previous ocular trauma
Patients with ocular blunt trauma	Optical Coherence Tomography Angiography	Patients with previous ocular blunt trauma in one eye.

Primary Outcome Measures

Name	Time	Method
The measurements of retinal vessel density in patients after ocular blunt trauma during 6 months's follow up	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

Trial Locations

Locations (1)

University of Naples "Federico II"; 🇮🇹 Naples, Italy