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OCTA Study of Choroidal Vasculature in Open Angle Glaucoma Patients

Sponsor
Federico II University (Other)
Overall Status
Completed
CT.gov ID
NCT05455567
Collaborator
(none)
57
Enrollment
1
Location
3.4
Actual Duration (Months)
16.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: OCTA

Study Design

Study Type:
Observational
Actual Enrollment :
57 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
OCTA as a New Biomarker in the Pathogenesis of Primary Open Angle Glaucoma
Actual Study Start Date :
Feb 1, 2022
Actual Primary Completion Date :
Apr 30, 2022
Actual Study Completion Date :
May 15, 2022

Arms and Interventions

Arm Intervention/Treatment
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
healthy patients

Diagnostic Test: OCTA
Choriocapillary vessel density calculated with OCTA

Outcome Measures

Primary Outcome Measures

  1. The measurements of choroidal thickness and choriocapillary vessel density in patients with open angle glaucoma. [up to 5 months]

    correlation of measurement of choroidal thickness and choriocapillary vessel density in three different patients groups

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Naples "Federico II" Naples Italy 80100

Sponsors and Collaborators

  • Federico II University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gilda Cennamo, professor, Federico II University
ClinicalTrials.gov Identifier:
NCT05455567
Other Study ID Numbers:
  • 0102/22
First Posted:
Jul 13, 2022
Last Update Posted:
Jul 25, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle

Study Results

No Results Posted as of Jul 25, 2022