GlaucomaNCT05801471
Clinical Evaluation of Visual Field Change in Glaucoma: an Assessment of Different Models of Progression
An observational study of Glaucoma, run by Centervue SpA at 2 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Glaucoma
- How many people
- 200 participants
- Where
- 2 sitesItaly
- Study dates
- 6 May 2022to 6 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult, both males and females, 40-90 years old with diagnosis of Glaucoma
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Clinica oculistica Ospedale San Paolo
Milan, Milano, 20142
Luca M Rossetti, Prof., 02/81844556 ext. +39, luca.rossetti@unimi.it
Luca M. Rossetti, Prof.
- Recruiting
Glaucoma Research Center, IRCCS Fondazione "G.B. Bietti"
Roma, Roma, 00184
Francesco Oddone, Dott., 06.85356727 ext. +39, francesco.oddone@fondazionebietti.it
Francesco Oddone, Dott.
About this study
Official title: An Observational Prospective Longitudinal Study for the Clinical Evaluation of Visual Field Change in Glaucoma. An Assessment of Different Models of Progression
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.
- Conditions
- Glaucoma
- Medical subject headings
- Glaucoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Equivalence between Compass and HFA in terms of estimation of the global progression rate (MD progression slope).
Equivalence will be defined as the 95% confidence Intervals of the mean difference between the slopes estimated with the two devices being within ± 0.1 dB/year
Measured: 1 visit every 4 months (10 visits total), up to 3 years
Secondary outcomes (2)
Difference in time to identify progression between Compass and HFA using an event analysis
Time of first detectable change [years]
Measured: 1 visit every 4 months (10 visits total), up to 3 years
Quantification of the effect of the integration of the rate of progression of structural metrics into the calculation of the rate of progression of the MD
Quantification of the effect of the integration of the rate of progression of structural metrics (mainly the retinal nerve fiber layer thickness, microns/year) into the calculation of the rate of progression of the MD. This effect will be quantified as the improvement in the equivalence metric defined for Outcome 1
The integration of structural OCT RNFL thickness information into progression analysis will be done using a Bayesian Linear Regression approach as suggested by Russel at al.[*]
[*] R.A. Russel at al.; "Improved Estimates of Visual Field Progression Using Bayesian Linear Regression to Integrate Structural Information in Patients with Ocular Hypertension"; IOVS May 2012; 53(6): 2760-2769.
Measured: 1 visit every 4 months (10 visits total), up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start6 May 2022
- Primary completion6 Nov 2028 (estimated)
- Study completion6 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centervue SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luca M. Rossetti, Prof., Principal investigator, Clinica oculistica Ospedale San Paolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801471
- Sponsor's protocol ID
- CMP_005
- Status last verified
- Dec 2025
- First submitted
- 7 Mar 2023
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Prospective Longitudinal Study for the Clinical Evaluation of Visual Field Change in Glaucoma. An Assessment of Different Models of Progression
- ClinicalTrials.gov ID
- NCT05801471
- Acronym / sponsor ID
- CMP_005
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centervue SpAIndustry (pharma, biotech, devices)
- Study start
- 6 May 2022 (actual)
- Primary completion
- 6 Nov 2028 (estimated)
- Study completion
- 6 Nov 2028 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult, both males and females, 40-90 years old with diagnosis of Glaucoma
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Equivalence between Compass and HFA in terms of estimation of the global progression rate (MD progression slope).
Time frame: 1 visit every 4 months (10 visits total), up to 3 years
Equivalence will be defined as the 95% confidence Intervals of the mean difference between the slopes estimated with the two devices being within ± 0.1 dB/year
2 secondary outcomes
Difference in time to identify progression between Compass and HFA using an event analysis
Time frame: 1 visit every 4 months (10 visits total), up to 3 years
Quantification of the effect of the integration of the rate of progression of structural metrics into the calculation of the rate of progression of the MD
Time frame: 1 visit every 4 months (10 visits total), up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luca M. Rossetti, Prof. principal investigator
Clinica oculistica Ospedale San Paolo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Centervue SpA at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiara Rui (+39 049 501 8399, chiara.rui@icare-world.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Equivalence between Compass and HFA in terms of estimation of the global progression rate (MD progression slope). (time frame: 1 visit every 4 months (10 visits total), up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.