Clinical Evaluation of Visual Field Change in Glaucoma: an Assessment of Different Models of Progression
Recruiting · NCT05801471 · Observational (researchers observe without assigning treatment) · Lead sponsor: Centervue SpA
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
40 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
2 locations listed.
- Clinica oculistica Ospedale San Paolo - Milan, Milano, Italy
- Glaucoma Research Center, IRCCS Fondazione "G.B. Bietti" - Roma, Roma, Italy