Clinical Evaluation of Visual Field Change in Glaucoma: an Assessment of Different Models of Progression

An Observational Prospective Longitudinal Study for the Clinical Evaluation of Visual Field Change in Glaucoma. An Assessment of Different Models of Progression

The purpose of this observational study is to collect over time a series of data in patients with glaucoma in order to evaluate different approaches in defining the progression of this pathology. These data will be collected in repeated visits over a 36-months follow-up period. At each visit, the COMPASS fundus perimeter and the Humphrey Field Analyzer (HFA) perimeter will be used to assess retinal functionality; an Optical Coherence Tomography (OCT) examination will also be performed to evaluate and obtain clinical information about the structure of the retina.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Chiara Rui; Phone Number: +39 049 501 8399; Email: chiara.rui@icare-world.com

Study Locations

• Italy
  • Milano
    • Milan, Milano, Italy, 20142
      • Recruiting
      • Clinica oculistica Ospedale San Paolo
      • Contact: Luca M Rossetti, Prof.; Phone Number: +39 02/81844556; Email: luca.rossetti@unimi.it
      • Principal Investigator: Luca M. Rossetti, Prof.
      • Sub-Investigator: Paolo Fogagnolo, Dott.
  • Roma
    • Roma, Roma, Italy, 00184
      • Recruiting
      • Glaucoma Research Center, IRCCS Fondazione "G.B. Bietti"
      • Contact: Francesco Oddone, Dott.; Phone Number: +39 06.85356727; Email: francesco.oddone@fondazionebietti.it
      • Principal Investigator: Francesco Oddone, Dott.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult, both males and females, 40-90 years old with diagnosis of Glaucoma

Description

Inclusion Criteria:

• Glaucomatous optic nerve head in both eyes;
• Age between 40 and 90 years;
• Best Corrected Visual Acuity ≤ 0.3 [logMar];
• Spherical refraction between -6D and +6D;
• Astigmatism between -2D and +2D.

Exclusion Criteria:

• Any ocular surgery, except for: uncomplicated cataract surgery and/or glaucoma surgery in both eyes performed within 6 months before enrollment;
• Any ocular pathology that can affect visual field other than glaucoma;
• Use of any drug that can interfere with the correct execution of perimetry or that would produce visual field loss;
• Inability to obtain reliable perimetric examinations;
• Patients with advanced glaucoma for whom, according to the clinician, a 24-2 grid is not advisable to correctly monitor the patient.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Equivalence between Compass and HFA in terms of estimation of the global progression rate (MD progression slope).	Equivalence will be defined as the 95% confidence Intervals of the mean difference between the slopes estimated with the two devices being within ± 0.1 dB/year	1 visit every 4 months (10 visits total), up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in time to identify progression between Compass and HFA using an event analysis	Time of first detectable change [years]	1 visit every 4 months (10 visits total), up to 3 years
Quantification of the effect of the integration of the rate of progression of structural metrics into the calculation of the rate of progression of the MD	Quantification of the effect of the integration of the rate of progression of structural metrics (mainly the retinal nerve fiber layer thickness, microns/year) into the calculation of the rate of progression of the MD. This effect will be quantified as the improvement in the equivalence metric defined for Outcome 1 The integration of structural OCT RNFL thickness information into progression analysis will be done using a Bayesian Linear Regression approach as suggested by Russel at al.[*] [*] R.A. Russel at al.; "Improved Estimates of Visual Field Progression Using Bayesian Linear Regression to Integrate Structural Information in Patients with Ocular Hypertension"; IOVS May 2012; 53(6): 2760-2769.	1 visit every 4 months (10 visits total), up to 3 years

Collaborators and Investigators

• Sponsor: Centervue SpA
• Investigators: Principal Investigator: Luca M. Rossetti, Prof., Clinica oculistica Ospedale San Paolo

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2022
• Primary Completion (Estimated): November 6, 2028
• Study Completion (Estimated): November 6, 2028

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: CMP_005

Plan for Individual participant data (IPD)

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