Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT06827535
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-18
First Post:
2025-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Vascular, Functional and Morphological Changes in Glaucoma and Ocular Hypertensive Patients
Sponsor:
Mario Stirpe
Organization:
Study Overview
Official Title:
Long-term Vascular, Functional and Morphological Changes in Glaucoma and Ocular Hypertensive Patients
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Ippocrate
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: