NCT06827535Enrolling by invitation
Long-term Vascular, Functional and Morphological Changes in Glaucoma and Ocular Hypertensive Patients
Source: ClinicalTrials.gov · Last updated 18 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 30 Jan 2025
- Start date
- 14 Nov 2024
- Primary completion date
- 14 Nov 2028
- Lead sponsor
- Mario Stirpe
- Diseases
- Glaucoma, High blood pressure
- NCT number
- NCT06827535
What you commit to
- Study type: Observational
- Planned participants: 400
- From 14 Nov 2024 to the primary completion date, 14 Nov 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous eye surgery, except glaucoma surgery or removal of cataracts performed more than 6 months prior to enrollment
Other
- BCVA \<5/10
- Other pathologies that can cause alterations of the optic nerve or visual field defects
- Presence of maculopathies
- Inability to perform visual field tests
- Opacity of the dioptric media such that it is not possible to perform reliable OCT and OCTA of acceptable quality
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinica Oculistica, DiNOGMI, Università di Genova Coordinator of this site? Confirm its status | Genoa | Italy | Unknown status |
| Ospedale San Paolo - ASST Santi Paolo e Carlo Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Ospedale Maggiore della Carità Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
| IRCCS-Fondazione GB Bietti Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Azienda Ospedaliera Universitaria di Sassari, Dipartimento di Medicina, Chirurgia e Farmacologia Università di Sassari Coordinator of this site? Confirm its status | Sassari | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.