Menu
Enrolling by invitation NCT06827535

Long-term Vascular, Functional and Morphological Changes in Glaucoma and Ocular Hypertensive Patients

— Observational Glaucoma Ocular Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Glaucoma, Ocular Hypertension. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Rate of disease progression [Time frame: Up to 3 years]
Secondary outcome measures (4)
  • Rate of disease progression in relation to age [Time frame: Up to 3 years]
  • Rate of disease progression in relation to myopia [Time frame: Up to 3 years]
  • Rate of disease progression in relation to demographic data [Time frame: Up to 3 years]
  • Quality of life in glaucoma and ocular hypertensive patients [Time frame: Up to 3 years]

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

  • BCVA <5/10
  • Previous eye surgery, except glaucoma surgery or removal of cataracts performed more than 6 months prior to enrollment
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Italy · 5 centers
  • Ospedale San Paolo - ASST Santi Paolo e Carlo — Milan
  • Ospedale Maggiore della Carità — Novara
  • Irccs-Fondazione Gb Bietti — Rome
  • Azienda Ospedaliera Universitaria di Sassari, Dipartimento di Medicina, Chirurgia e Farmac — Sassari
  • Clinica Oculistica, DiNOGMI, Università di Genova — Genoa

Publications

  • Sotimehin AE, Ramulu PY. Measuring Disability in Glaucoma. J Glaucoma. 2018 Nov;27(11):939-949. doi: 10.1097/IJG.0000000000001068. PMID 30161076
  • 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. PMID 12365904

Identifiers

NCT: NCT06827535 · GLC 04-24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗