An Observational Prospective Longitudinal Study for the Clinical Evaluation of Visual Field Change in Glaucoma. An Assessment of Different Models of Progression
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Glaucoma
- Sponsor
- Centervue SpA
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Equivalence between Compass and HFA in terms of estimation of the global progression rate (MD progression slope).
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
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
- 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)
- 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)