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

• Conditions: Glaucoma; Ocular Hypertension

• Registration Number: NCT06827535
• Lead Sponsor: Mario Stirpe

Brief 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.

Study Timeline

• Study Start: 2024-11-14
• Status Verified: 2025-01
• Study First Submitted: 2025-01-30
• Study First Submitted QC: 2025-02-13
• Study First Posted: 2025-02-14
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18
• Primary Completion: 2028-11-14
• Study Completion: 2030-01-02

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Rate of disease progression in relation to age	Up to 3 years	Rate of progression of functional, morphological and vascular parameters, in relation to age
Rate of disease progression in relation to myopia	Up to 3 years	Rate of progression of functional, morphological and vascular parameters, in relation to myopia
Rate of disease progression in relation to demographic data	Up to 3 years	Rate of progression of functional, morphological and vascular parameters, in relation to clinical and demographic factors collected at baseline (visual acuity, axial length, diagnosis, sex, stage of the disease, etc.)
Quality of life in glaucoma and ocular hypertensive patients	Up to 3 years	Quality of life questionnaire (National Eye Institute Visual Function Questionnaire-25) scores over time.; The minimum value is 0, the maximum value is 100. Higher score means a better outcome.

Trial Locations

Locations (5)

Clinica Oculistica, DiNOGMI, Università di Genova; 🇮🇹 Genoa, Italy

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