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Enrolling by invitation Observational

Long-term Vascular, Functional and Morphological Changes in Glaucoma and Ocular Hypertensive Patients

NCT06827535 · tracked via the Priya Life Science Italy tracker
Sponsor
Mario Stirpe
Phase
Observational
Started
2024-11-14
Last updated
2025-02-18

Condition(s) studied

GlaucomaOcular Hypertension

Study summary

This is an observational study involving patients with glaucoma, those with ocular hypertension and healthy subjects.

The aim of the study is the long term evaluation of functional, vascular and morphological changes in glaucoma and ocular hypertensive patients, compared to healthy subjects, to analyze the temporal relationship of these changes.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Diagnosis of primary glaucoma (open or closed angle) or secondary glaucoma (pseudoexfoliative or pigmentary) defined by the presence of a glaucomatous defect of the optic nerve and/or a perimetric glaucomatous defect as defined by the European guidelines * Diagnosis of ocular hypertension (defined by the presence of intraocular pressure values≥22 mmHg, optic nerve and visual field examination within normal limits) * No Optic nerve disease and IOP\<21mmHg for healthy subjects * Age\>18 years * Able to read and sing the informed consent form Exclusion Criteria: 1. BCVA \<5/10 2. Previous eye surgery, except glaucoma surgery or removal of cataracts performed more than 6 months prior to enrollment 3. Other pathologies that can cause alterations of the optic nerve or visual field defects 4. Presence of maculopathies 5. Inability to perform visual field tests 6. Opacity of the dioptric media such that it is not possible to perform reliable OCT and OCTA of acceptable quality

Primary outcome measure(s)

  • Rate of disease progression — Up to 3 years
    Rate of progression of functional, morphological and vascular parameters, calculated on the basis of tests repeated over time

Trial sites (5)

FacilityCityRegionStatus
Ospedale San Paolo - ASST Santi Paolo e Carlo Milan Italy
Ospedale Maggiore della Carità Novara Italy
Irccs-Fondazione Gb Bietti Rome Italy
Azienda Ospedaliera Universitaria di Sassari, Dipartimento di Medicina, Chirurgia e Farmacologia Università di Sassari Sassari Italy
Clinica Oculistica, DiNOGMI, Università di Genova Genoa Italy

More Mario Stirpe trials in Italy

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 NCT06827535 on ClinicalTrials.gov ↗ ← All trials in Italy