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Enrolling by Invitation

NCT Number: NCT06827535

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale San Paolo - ASST Santi Paolo e Carlo, Milan, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Rate of disease progression

    Time frame: Up to 3 years

    Rate of progression of functional, morphological and vascular parameters, calculated on the basis of tests repeated over time

Secondary outcomes

  1. Rate of disease progression in relation to age

    Time frame: Up to 3 years

    Rate of progression of functional, morphological and vascular parameters, in relation to age

  2. Rate of disease progression in relation to myopia

    Time frame: Up to 3 years

    Rate of progression of functional, morphological and vascular parameters, in relation to myopia

  3. Rate of disease progression in relation to demographic data

    Time frame: Up to 3 years

    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.)

  4. Quality of life in glaucoma and ocular hypertensive patients

    Time frame: Up to 3 years

    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.

Sponsors and collaborators

Lead sponsor

Mario Stirpe

Other

Registry information

Acronym: Ippocrate

Important dates

Study start
2024
Primary completion
2028
Study completion
2030
First posted
Feb 14, 2025
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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