Clinical trial NCT06827535: Long-term Vascular, Functional and Morphological Changes in Glaucoma and Ocular Hypertensive Patients
Official title: Long-term Vascular, Functional and Morphological Changes in Glaucoma and Ocular Hypertensive Patients
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Glaucoma
Ocular Hypertension
Keywords: glaucoma
ocular hypertension
vascular changes
morphological changes
functional changes
Lead sponsor: Fondazione G.B. Bietti, IRCCS
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People attending the hospital

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of disease progression
timeFrame: Up to 3 years
Secondary outcomes:
measure: Rate of disease progression in relation to age
timeFrame: Up to 3 years
measure: Rate of disease progression in relation to myopia
timeFrame: Up to 3 years
measure: Rate of disease progression in relation to demographic data
timeFrame: Up to 3 years
measure: Quality of life in glaucoma and ocular hypertensive patients
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: Clinica Oculistica, DiNOGMI, Università di Genova
city: Milan
country: Italy
facility: Ospedale San Paolo - ASST Santi Paolo e Carlo
city: Novara
country: Italy
facility: Ospedale Maggiore della Carità
city: Rome
country: Italy
facility: Irccs-Fondazione Gb Bietti
city: Sassari
country: Italy
facility: Azienda Ospedaliera Universitaria di Sassari, Dipartimento di Medicina, Chirurgia e Farmacologia Università di Sassari
Study officials:
References:
citation: Sotimehin AE, Ramulu PY. Measuring Disability in Glaucoma. J Glaucoma. 2018 Nov;27(11):939-949. doi: 10.1097/IJG.0000000000001068.
citation: 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.