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

Mario Stirpe

Status: Invitation-only

Conditions: Glaucoma; Ocular Hypertension

Study type: Observational

Funder types: Other

Identifiers

NCT06827535

GLC 04-24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

400 participants in 3 patient groups

Glaucoma

Description:

iagnosis 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 European guidelines

Ocular Hypertension

Description:

Diagnosis of ocular hypertension (defined by the presence of intraocular pressure values ≥22 mmHg, optic nerve and visual field examination within normal limits).

Healthy subjects

Description:

No optic nerve disease IOP \< 21 mmHg