GlaucomaNCT06227611
Evaluation of Different Perimetric Grids to Detect Central Visual Field Defect in Glaucoma Patients With Reduce Ganglion Cell Layer Thickness Measured by Spectral Domain OCT.
An observational study of Glaucoma, run by Fondazione G.B. Bietti, IRCCS at 2 sites in Italy.
Trial summary
The aim of the study is to evaluate the agreement between three different grids in detecting central visual field defect in early glaucoma patients with reduced ganglion cell layer thickness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- How many people
- 16 participants
- Where
- 2 sitesItaly
- Study dates
- 4 May 2021to 4 May 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: glaucoma patients referring to glaucoma clinic of IRCCS-Fondazione GB Bietti and University of Rome Tor Vergata.
Who may be able to join
- glaucoma patients with glaucomatous optic nerve head defect and reduced ganglion cell layer thickness
Who cannot join
- age<18 years
- unable to read, understand and sign the written informed consent
- unable to perform visual field test
- advanced glaucoma with C/D>0.7
- other causes of optic neuropathies
- retinal or macular diseases
Show all 9Show fewer
- lens or corneal opacities
- spherical refractive defect >± 6D
- cylindric refractive defect >± 3D
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
IRCCS-Fondazione GB Bietti
Rome
Gloria Roberti, PhD, +390685356727, gloria.roberti@fondazionebietti.it
- Recruiting
University of Rome Tor Vergata
Rome
Gianluca Manni, MD, +3906209001, gianlucamanni53@gmail.com
About this study
The aim of the study is to evaluate the agreement between three different grids in detecting central visual field defect in early glaucoma patients with reduced ganglion cell layer thickness.
- Conditions
- Glaucoma
- Medical subject headings
- Glaucoma
What is being measured
The primary outcome is the main question the study is designed to answer.
the agreement between 10-2 HFA and 24-2c HFA in detecting central visual field defect
central visual field is defined by the presence of a cluster of three test locations with significantly reduced sensitivity in a hemifield fo the pattern deviation plot.
Measured: 12 month
Secondary outcomes (1)
the agreement between 24-2c HFA and G1 Octopus in detecting central visual field defect
central visual field is defined by the presence of a cluster of three test locations with significantly reduced sensitivity in a hemifield fo the pattern deviation plot.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start4 May 2021
- Primary completion4 May 2022
- Study completion4 May 2029 (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
- Cross-sectional
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione G.B. Bietti, IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227611
- Sponsor's protocol ID
- GLC04-20
- Status last verified
- Sep 2025
- First submitted
- 18 Jan 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Perimetric Grids to Detect Central Visual Field Defect in Glaucoma Patients With Reduce Ganglion Cell Layer Thickness Measured by Spectral Domain OCT.
- ClinicalTrials.gov ID
- NCT06227611
- Acronym / sponsor ID
- GLC04-20
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Fondazione G.B. Bietti, IRCCSUniversity, hospital or other
- Study start
- 4 May 2021 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 4 May 2029 (estimated)
- First posted
- 29 Jan 2024 (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 aim of the study is to evaluate the agreement between three different grids in detecting central visual field defect in early glaucoma patients with reduced ganglion cell layer thickness.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- glaucoma patients referring to glaucoma clinic of IRCCS-Fondazione GB Bietti and University of Rome Tor Vergata.
Key inclusion criteria (1 listed)
- glaucoma patients with glaucomatous optic nerve head defect and reduced ganglion cell layer thickness
Key exclusion criteria (9 listed)
- age<18 years
- unable to read, understand and sign the written informed consent
- unable to perform visual field test
- advanced glaucoma with C/D>0.7
- other causes of optic neuropathies
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
the agreement between 10-2 HFA and 24-2c HFA in detecting central visual field defect
Time frame: 12 month
central visual field is defined by the presence of a cluster of three test locations with significantly reduced sensitivity in a hemifield fo the pattern deviation plot.
1 secondary outcome
the agreement between 24-2c HFA and G1 Octopus in detecting central visual field defect
Time frame: 12 month
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 3 Sep 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.
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 Fondazione G.B. Bietti, IRCCS 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 1 inclusion and 9 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 3 Sep 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the agreement between 10-2 HFA and 24-2c HFA in detecting central visual field defect (time frame: 12 month). 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 3 Sep 2026.