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

N/AEnrolling By InvitationNCT06827535

Mario Stirpe400 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

400

Conditions

Glaucoma Ocular Hypertension

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (5)

Ospedale San Paolo - ASST Santi Paolo e Carlo

Milan, Italy, Italy

Ospedale Maggiore della Carità

Novara, Italy, Italy

Irccs-Fondazione Gb Bietti

Rome, Italy, Italy

Azienda Ospedaliera Universitaria di Sassari, Dipartimento di Medicina, Chirurgia e Farmacologia Università di Sassari

Sassari, Italy, Italy

Outcomes

Primary Outcomes

Rate of disease progression

Rate of progression of functional, morphological and vascular parameters, calculated on the basis of tests repeated over time

Time frame: Up to 3 years

Secondary Outcomes

Rate of disease progression in relation to age

Rate of progression of functional, morphological and vascular parameters, in relation to age

Time frame: Up to 3 years

Rate of disease progression in relation to myopia

Rate of progression of functional, morphological and vascular parameters, in relation to myopia

Time frame: Up to 3 years

Rate of disease progression in relation to demographic data

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.)

Time frame: Up to 3 years

Quality of life in glaucoma and ocular hypertensive patients

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.

Time frame: Up to 3 years

Data from ClinicalTrials.gov

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