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

Study Overview
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Brief Summary
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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.

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

Conditions
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Glaucoma

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 |