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

NCT05801471 | Recruiting

• 1 other identifier: CMP_005
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Difference in time to identify progression between Compass and HFA using an event analysis

  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

  1 visit every 4 months (10 visits total), up to 3 years

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centervue SpA: lead

Study Sites (2)

Clinica oculistica Ospedale San Paolo

Milan, Milano, 20142, Italy

RECRUITING

Glaucoma Research Center, IRCCS Fondazione "G.B. Bietti"

Roma, Roma, 00184, Italy

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Luca M. Rossetti, Prof.

  Clinica oculistica Ospedale San Paolo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiara Rui

CONTACT

+39 049 501 8399; chiara.rui@icare-world.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: April 6, 2023
• Study Start: May 6, 2022
• Primary Completion (Estimated): November 6, 2028
• Study Completion (Estimated): November 6, 2028
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)