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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica oculistica Ospedale San Paolo, Milan, Milano, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Equivalence between Compass and HFA in terms of estimation of the global progression rate (MD progression slope).

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

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

Secondary outcomes

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

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

Time of first detectable change [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

Time frame: 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 (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.

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Sponsors and collaborators

Lead sponsor

Centervue SpA

Industry

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2028
Study completion: 2028
First posted: Apr 6, 2023
Registry last updated: Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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