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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.
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult, both males and females, 40-90 years old with diagnosis of Glaucoma
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chiara Rui | Contact | +39 049 501 8399 | chiara.rui@icare-world.com |
| Name | Affiliation | Role |
|---|---|---|
| Luca M. Rossetti, Prof. | Clinica oculistica Ospedale San Paolo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica oculistica Ospedale San Paolo | Recruiting | Milan | Milano | 20142 | Italy |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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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 |
| Glaucoma Research Center, IRCCS Fondazione "G.B. Bietti" | Recruiting | Roma | Roma | 00184 | Italy |
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