Clinical Evaluation of Visual Field Change in Glaucoma: an Assessment of Different Models of Progression
ConditionGlaucoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-90
SponsorCentervue SpA
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial population
Adult, both males and females, 40-90 years old with diagnosis of Glaucoma
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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
Time frame
1 visit every 4 months (10 visits total), up to 3 yearsSecondary outcomes
1
Difference in time to identify progression between Compass and HFA using an event analysis
Time of first detectable change \[years\]
Time frame
1 visit every 4 months (10 visits total), up to 3 years2
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.
Time frame
1 visit every 4 months (10 visits total), up to 3 yearsSponsors and contacts
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Source ClinicalTrials.gov