Clinical Evaluation of Visual Field Change in Glaucoma: an Assessment of Different Models of Progression

NCT ID: NCT05801471

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-06

Study Completion Date

2028-11-06

Brief Summary

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The purpose of this observational study is to collect over time a series of data in patients with glaucoma in order to evaluate different approaches in defining the progression of this pathology. These data will be collected in repeated visits over a 36-months follow-up period. At each visit, the COMPASS fundus perimeter and the Humphrey Field Analyzer (HFA) perimeter will be used to assess retinal functionality; an Optical Coherence Tomography (OCT) examination will also be performed to evaluate and obtain clinical information about the structure of the retina.

Detailed Description

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Conditions

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Glaucoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Glaucomatous optic nerve head in both eyes;
* Age between 40 and 90 years;
* Best Corrected Visual Acuity ≤ 0.3 \[logMar\];
* Spherical refraction between -6D and +6D;
* Astigmatism between -2D and +2D.

Exclusion Criteria

* Any ocular surgery, except for: uncomplicated cataract surgery and/or glaucoma surgery in both eyes performed within 6 months before enrollment;
* Any ocular pathology that can affect visual field other than glaucoma;
* Use of any drug that can interfere with the correct execution of perimetry or that would produce visual field loss;
* Inability to obtain reliable perimetric examinations;
* Patients with advanced glaucoma for whom, according to the clinician, a 24-2 grid is not advisable to correctly monitor the patient.
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centervue SpA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luca M. Rossetti, Prof.

Role: PRINCIPAL_INVESTIGATOR

Clinica oculistica Ospedale San Paolo

Locations

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Clinica oculistica Ospedale San Paolo

Milan, Milano, Italy

Site Status RECRUITING

Glaucoma Research Center, IRCCS Fondazione "G.B. Bietti"

Roma, Roma, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Chiara Rui

Role: CONTACT

+39 049 501 8399

Facility Contacts

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Luca M Rossetti, Prof.

Role: primary

02/81844556 ext. +39

Francesco Oddone, Dott.

Role: primary

06.85356727 ext. +39

Other Identifiers

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CMP_005

Identifier Type: -

Identifier Source: org_study_id

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