Clinical Evaluation of Visual Field Change in Glaucoma: an Assessment of Different Models of Progression
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- Equivalence between Compass and HFA in terms of estimation of the global progression rate (MD progression slope). [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 Outcome Measures
- 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]
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 [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Glaucomatous optic nerve head in both eyes;
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Age between 40 and 90 years;
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Best Corrected Visual Acuity ≤ 0.3 [logMar];
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Spherical refraction between -6D and +6D;
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Astigmatism between -2D and +2D.
Exclusion Criteria:
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Any ocular surgery, except for: uncomplicated cataract surgery and/or glaucoma surgery in both eyes performed within 6 months before enrollment;
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Any ocular pathology that can affect visual field other than glaucoma;
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Use of any drug that can interfere with the correct execution of perimetry or that would produce visual field loss;
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Inability to obtain reliable perimetric examinations;
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Patients with advanced glaucoma for whom, according to the clinician, a 24-2 grid is not advisable to correctly monitor the patient.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinica oculistica Ospedale San Paolo | Milano | Italy | 20142 | |
| 2 | Glaucoma Research Center, IRCCS Fondazione "G.B. Bietti" | Roma | Italy | 00184 |
Sponsors and Collaborators
- Centervue SpA
Investigators
- Principal Investigator: Luca M. Rossetti, Prof., Clinica oculistica Ospedale San Paolo
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CMP_005