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.

NCT06227611 | Recruiting

• 1 other identifier: GLC04-20
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the agreement between 24-2c HFA and G1 Octopus in detecting central visual field defect

  12 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione G.B. Bietti, IRCCS: lead

Study Sites (2)

IRCCS-Fondazione GB Bietti

Rome, Italy

RECRUITING

University of Rome Tor Vergata

Rome, Italy

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 29, 2024
• Study Start: May 4, 2021
• Primary Completion: May 4, 2022
• Study Completion: May 4, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)