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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | ||
| 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). | ||
| Healthy subjects | No optic nerve disease IOP < 21 mmHg |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of disease progression | Rate of progression of functional, morphological and vascular parameters, calculated on the basis of tests repeated over time | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of disease progression in relation to age | Rate of progression of functional, morphological and vascular parameters, in relation to age | Up to 3 years |
| Rate of disease progression in relation to myopia |
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Inclusion Criteria:
Exclusion Criteria:
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People attending the hospital
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale San Paolo - ASST Santi Paolo e Carlo | Milan | Italy | 20142 | Italy | ||
| Ospedale Maggiore della Carità |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30161076 | Background | Sotimehin AE, Ramulu PY. Measuring Disability in Glaucoma. J Glaucoma. 2018 Nov;27(11):939-949. doi: 10.1097/IJG.0000000000001068. | |
| 12365904 | Background | Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M; Early Manifest Glaucoma Trial Group. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002 Oct;120(10):1268-79. doi: 10.1001/archopht.120.10.1268. |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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Rate of progression of functional, morphological and vascular parameters, in relation to myopia
| 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.) | 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. | Up to 3 years |
| Novara |
| Italy |
| 28100 |
| Italy |
| Irccs-Fondazione Gb Bietti | Rome | Italy | 00184 | Italy |
| Azienda Ospedaliera Universitaria di Sassari, Dipartimento di Medicina, Chirurgia e Farmacologia Università di Sassari | Sassari | Italy | 07100 | Italy |
| Clinica Oculistica, DiNOGMI, Università di Genova | Genoa | Italy |