Glaucoma Open-Angle PrimaryGLAUDIANCT07210216
GLAUcoma Diagnostic and Imaging Analysis (GLAUDIA) Study
An observational study of Glaucoma Open-Angle Primary and Ocular Hypertension, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
This observational study aims to identify early diagnostic markers of glaucomatous damage by combining functional and structural assessments. Patients with primary open-angle glaucoma and ocular hypertension will undergo comprehensive ophthalmological evaluation, including visual field testing and multimodal imaging… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Glaucoma Open-Angle Primary, Ocular Hypertension
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Jun 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
- Adult, Older adult
Study population: Adult patients (40-90 years) with primary open-angle glaucoma, ocular hypertension, or healthy controls, recruited at the Glaucoma Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS.
Who may be able to join
- Age between 40 and 90 years.
- Best-corrected visual acuity ≥ 0.1 LogMAR (≥ 8/10).
- For primary open-angle glaucoma (POAG):
- IOP ≥ 21 mmHg with normal visual field and/or normal optic nerve head/RNFL, or
- Suspicious optic nerve head (excavation), or
- Reproducible glaucomatous visual field defect.
- POAG patients stratified by visual field mean deviation (MD): -3 to -10 dB (S1-S2 Brusini classification).
Who cannot join
- Best-corrected visual acuity worse than 0.1 LogMAR (< 8/10).
- Ocular surgery in the last 6 months (except uncomplicated cataract extraction).
- Previous vitreoretinal surgery for macular pathologies (e.g., macular pucker, macular hole) or retinal detachment.
- High myopia (> -3 diopters).
- Optic disc anomalies not attributable to glaucoma (tilted disc, papillary drusen, other morphological/functional anomalies).
- Severe motor disability preventing proper positioning for tests.
- Cognitive impairment reducing test reliability.
About this study
Official title: New Diagnostic Paradigms for the Identification of Early Glaucomatous Damage
This observational study aims to identify early diagnostic markers of glaucomatous damage by combining functional and structural assessments. Patients with primary open-angle glaucoma and ocular hypertension will undergo comprehensive ophthalmological evaluation, including visual field testing and multimodal imaging of the optic nerve and retina. Both retrospective and prospective data will be collected. The main objective is to define new diagnostic paradigms for detecting early glaucomatous changes and to improve the accuracy of current clinical practice in glaucoma management.
- Conditions
- Glaucoma Open-Angle Primary, Ocular Hypertension
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of early glaucomatous damage detected by multimodal imaging
Evaluation of structural parameters from OCT and OCTA and functional indices from visual field testing to detect early glaucomatous damage in ocular hypertensive and glaucoma patients.
Measured: Baseline to 24 months
Secondary outcomes (1)
Correlation between OCT structural parameters and visual field indices
Analysis of the association between RNFL/GCC thickness and visual field MD, PSD, and other indices.
Measured: Baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study startOct 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma Open-Angle PrimaryStudies 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
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210216
- Sponsor's protocol ID
- 6441
- Acronym
- GLAUDIA
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Diagnostic Paradigms for the Identification of Early Glaucomatous Damage
- ClinicalTrials.gov ID
- NCT07210216
- Acronym / sponsor ID
- GLAUDIA / 6441
- Conditions
- Glaucoma Open-Angle Primary, Ocular Hypertension
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 7 Oct 2025 (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.
This observational study aims to identify early diagnostic markers of glaucomatous damage by combining functional and structural assessments. Patients with primary open-angle glaucoma and ocular hypertension will undergo comprehensive ophthalmological evaluation, including visual field testing and multimodal imaging of the optic nerve and retina. Both retrospective and prospective data will be collected. The main objective is to define new diagnostic paradigms for detecting early glaucomatous changes and to improve the accuracy of current clinical practice in glaucoma management.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients (40-90 years) with primary open-angle glaucoma, ocular hypertension, or healthy controls, recruited at the Glaucoma Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS.
Key inclusion criteria (7 listed)
- Age between 40 and 90 years.
- Best-corrected visual acuity ≥ 0.1 LogMAR (≥ 8/10).
- For primary open-angle glaucoma (POAG):
- IOP ≥ 21 mmHg with normal visual field and/or normal optic nerve head/RNFL, or
- Suspicious optic nerve head (excavation), or
Key exclusion criteria (7 listed)
- Best-corrected visual acuity worse than 0.1 LogMAR (< 8/10).
- Ocular surgery in the last 6 months (except uncomplicated cataract extraction).
- Previous vitreoretinal surgery for macular pathologies (e.g., macular pucker, macular hole) or retinal detachment.
- High myopia (> -3 diopters).
- Optic disc anomalies not attributable to glaucoma (tilted disc, papillary drusen, other morphological/functional anomalies).
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
Prevalence of early glaucomatous damage detected by multimodal imaging
Time frame: Baseline to 24 months
Evaluation of structural parameters from OCT and OCTA and functional indices from visual field testing to detect early glaucomatous damage in ocular hypertensive and glaucoma patients.
1 secondary outcome
Correlation between OCT structural parameters and visual field indices
Time frame: Baseline to 24 months
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 7 Oct 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma Open-Angle Primary and Ocular Hypertension, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of early glaucomatous damage detected by multimodal imaging (time frame: Baseline to 24 months). 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 7 Oct 2025.