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

NCT06827535 | Enrolling By Invitation

• 1 other identifier: GLC 04-24
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 5

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.

Conditions

Glaucoma; Ocular Hypertension

Keywords

glaucoma; ocular hypertension; vascular changes; morphological changes; functional changes

Outcome Measures

Primary Outcomes (1)

• Rate of disease progression

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

  Up to 3 years

Secondary Outcomes (4)

• Rate of disease progression in relation to age

  Up to 3 years

• Rate of disease progression in relation to myopia

  Up to 3 years

• Rate of disease progression in relation to demographic data

  Up to 3 years

• Quality of life in glaucoma and ocular hypertensive patients

  Up to 3 years

Study Arms (3)

Glaucoma

iagnosis 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 European guidelines

Ocular Hypertension

Diagnosis of ocular hypertension (defined by the presence of intraocular pressure values ≥22 mmHg, optic nerve and visual field examination within normal limits).

Healthy subjects

No optic nerve disease IOP \< 21 mmHg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People attending the hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mario Stirpe: lead

Study Sites (5)

Ospedale San Paolo - ASST Santi Paolo e Carlo

Milan, Italy, 20142, Italy

Location

Ospedale Maggiore della Carità

Novara, Italy, 28100, Italy

Location

Irccs-Fondazione Gb Bietti

Rome, Italy, 00184, Italy

Location

Azienda Ospedaliera Universitaria di Sassari, Dipartimento di Medicina, Chirurgia e Farmacologia Università di Sassari

Sassari, Italy, 07100, Italy

Location

Clinica Oculistica, DiNOGMI, Università di Genova

Genoa, Italy

Location

Related Publications (2)

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

  PMID: 30161076 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 14, 2025
• Study Start: November 14, 2024
• Primary Completion (Estimated): November 14, 2028
• Study Completion (Estimated): January 2, 2030
• Last Updated: February 18, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5)