NCT06827535

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Mario Stirpe · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. Secondary aims of the study are: * evaluating the effect of age on functional, morphological and vascular changes and their relationship, * evaluating the effect of myopia on functional, morphological and vascular changes and their relationship, * evaluating clinical and demographic factors associated with glaucoma onset and progression, * evaluating the effects of vascular, functional and morphological changes on quality of life During the study patients will undergo BCVA assessment, biomicroscopy, IOP measurement, CCT measurement, gonioscopy, visual field test, optic nerve head and macula OCT scan, OCT angiography scan, fundoscopy, every 6 months (for glaucoma and ocular hypertensive patients) and every 12 months (for healthy subjects). The study lasts 3 years. Four Italian glaucoma center will partecipate in this study, in addition to the promoter. Four hundred patients and 100 healthy subjects will be involved.

Conditions

• Glaucoma
• Ocular Hypertension

Timeline

• Start date: 2024-11-14
• Primary completion: 2028-11-14
• Completion: 2030-01-02
• First posted: 2025-02-14
• Last updated: 2025-02-18

Locations

5 sites across 1 country: Italy