Glaucoma, Ocular Hypertension
Conditions
Keywords
glaucoma, ocular hypertension, vascular changes, morphological changes, functional changes
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.
Interventions
None listed
Sponsors
Mario Stirpe
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Outcome results
None listed