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.

Glaucoma Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06227611
• Other study ID #: GLC04-20
• Status: Recruiting
• Start date: May 4, 2021
• Est. completion date: May 4, 2025

Study information

• Verified date: January 2024
• Source: Fondazione G.B. Bietti, IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: May 4, 2025
• Est. primary completion date: May 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Locations

Country	Name	City	State
Italy	IRCCS-Fondazione GB Bietti	Rome
Italy	University of Rome Tor Vergata	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione G.B. Bietti, IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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