NCT05455567

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

July 7, 2022

Last Update Submit

July 21, 2022

Conditions

Glaucoma Open-Angle Primary

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

patients with pre perimetric open angle glaucoma

Diagnostic Test: OCTA

patients with perimetric open angle glaucoma

Diagnostic Test: OCTA

healthy patients

Diagnostic Test: OCTA

Interventions

OCTADIAGNOSTIC_TEST

Choriocapillary vessel density calculated with OCTA

healthy patientspatients with perimetric open angle glaucomapatients with pre perimetric open angle glaucoma

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Naples "Federico II"

Naples, 80100, Italy

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 7, 2022

First Posted

July 13, 2022

Study Start

February 1, 2022

Primary Completion

April 30, 2022

Study Completion

May 15, 2022

Last Updated

July 25, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

Locations

IT(1)