OCTA Study of Choroidal Vasculature in Open Angle Glaucoma Patients

OCTA as a New Biomarker in the Pathogenesis of Primary Open Angle Glaucoma

The aim of the present study was to examine and measure SFCT and CCVD using respectively EDI-OCT and OCTA in preperimetric and advanced glaucomatous eyes, in order to shed light on the vascular pathogenesis of glaucoma disease.

Study Overview

• Status: Completed
• Conditions: Glaucoma Open-Angle Primary
• Intervention / Treatment: Diagnostic test: OCTA

• Study Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The participans were older than 40 years with diagnosis of open angle glaucoma. They did not present any other ophthalmological disease, diabetes, heart diseases and hypertension.

Description

Inclusion Criteria:• age older than 40 years

• diagnosis of glaucoma
• absence of diabetes, heart diseases, hypertension
• absence of drug intake
• absence of vitreoretinal, vascular retinal diseases
• absence of previous ocular surgery and congenital eye diseases.
• absence of errors of refraction
• absence of lens opacities
• absence of low-quality OCT and OCTA images

Exclusion Criteria:

• age younger than 40 years
• presence of diabetes, heart diseases, hypertension
• vitreoretinal and vascular retinal diseases
• previous ocular surgery and congenital eye diseases
• errors of refraction
• lens opacities
• low-quality OCT and OCTA images

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy patients	Diagnostic test: OCTA; Choriocapillary vessel density calculated with OCTA
patients with pre perimetric open angle glaucoma	Diagnostic test: OCTA; Choriocapillary vessel density calculated with OCTA
patients with perimetric open angle glaucoma	Diagnostic test: OCTA; Choriocapillary vessel density calculated with OCTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The measurements of choroidal thickness and choriocapillary vessel density in patients with open angle glaucoma.	correlation of measurement of choroidal thickness and choriocapillary vessel density in three different patients groups	up to 5 months

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): May 15, 2022

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 0102/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No