Evaluation of Different Perimetric Grids to Detect Central Visual Field Defect in Glaucoma Patients With Reduce Ganglion Cell Layer Thickness Measured by Spectral Domain OCT.

The aim of the study is to evaluate the agreement between three different grids in detecting central visual field defect in early glaucoma patients with reduced ganglion cell layer thickness.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma

• Study Type: Observational
• Enrollment (Estimated): 16

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy
    • Recruiting
    • University of Rome Tor Vergata
    • Contact: Gianluca Manni, MD; Phone Number: +3906209001; Email: gianlucamanni53@gmail.com
  • Rome, Italy
    • Recruiting
    • IRCCS-Fondazione GB Bietti
    • Contact: Gloria Roberti, PhD; Phone Number: +390685356727; Email: gloria.roberti@fondazionebietti.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

glaucoma patients referring to glaucoma clinic of IRCCS-Fondazione GB Bietti and University of Rome Tor Vergata.

Description

Inclusion Criteria:

• glaucoma patients with glaucomatous optic nerve head defect and reduced ganglion cell layer thickness

Exclusion Criteria:

• age<18 years
• unable to read, understand and sign the written informed consent
• unable to perform visual field test
• advanced glaucoma with C/D>0.7
• other causes of optic neuropathies
• retinal or macular diseases
• lens or corneal opacities
• spherical refractive defect >± 6D
• cylindric refractive defect >± 3D

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the agreement between 10-2 HFA and 24-2c HFA in detecting central visual field defect	central visual field is defined by the presence of a cluster of three test locations with significantly reduced sensitivity in a hemifield fo the pattern deviation plot.	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the agreement between 24-2c HFA and G1 Octopus in detecting central visual field defect	central visual field is defined by the presence of a cluster of three test locations with significantly reduced sensitivity in a hemifield fo the pattern deviation plot.	12 month

Collaborators and Investigators

• Sponsor: Fondazione G.B. Bietti, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2021
• Primary Completion (Actual): May 4, 2022
• Study Completion (Estimated): May 4, 2029

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): September 3, 2026
• Last Update Submitted That Met QC Criteria: September 2, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: GLC04-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No