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.

February 25, 2025 updated by: Fondazione G.B. Bietti, IRCCS
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

Study Type

Observational

Enrollment (Estimated)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 12 month
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
Time Frame: 12 month
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

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione G.B. Bietti, IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2021

Primary Completion (Actual)

May 4, 2022

Study Completion (Estimated)

May 4, 2025

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)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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