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Clinical Trials in Italy / NCT05801471
Recruiting Observational

Clinical Evaluation of Visual Field Change in Glaucoma: an Assessment of Different Models of Progression

NCT05801471 · tracked via the Priya Life Science Italy tracker
Sponsor
Centervue SpA
Phase
Observational
Started
2022-05-06
Last updated
2026-01-02

Condition(s) studied

Glaucoma

Study 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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
90 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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

Trial sites (2)

FacilityCityRegionStatus
Clinica oculistica Ospedale San Paolo Milan Milano Recruiting
Glaucoma Research Center, IRCCS Fondazione "G.B. Bietti" Roma Roma Recruiting

Other trials for the same condition

Long-term Vascular, Functional and Morphological Changes in Glaucoma and Ocular Hypertensive Patients Enrolling by invitation
Evaluation of Different Perimetric Grids to Detect Central Visual Field Defect in Glaucoma Patients With Reduce Ganglion Cell Layer Thickness Measured by Spectral Domain OCT. Recruiting
Nicotinamide Levels in Serum, Aqueous Humor, and Tear Film in Glaucoma and Correlations With Mitochondrial Damage-Associated Molecular Patterns (mtDAMPs) and Senescence-Associated Secretory Phenotype (SASP) Starting soon
Efficacy and Safety of XEN63 Gel Implant Enrolling by invitation
Retinal Ganglion Cell Neuroprotection Under Prostaglandin Analogues Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05801471 on ClinicalTrials.gov ↗ ← All trials in Italy