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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-14

Study Completion Date

2030-01-02

Brief Summary

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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.

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Detailed Description

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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

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Glaucoma Ocular Hypertension

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Glaucoma

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

No interventions assigned to this group

Ocular Hypertension

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

No interventions assigned to this group

Healthy subjects

No optic nerve disease IOP \< 21 mmHg

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes