GLAUcoma Diagnostic and Imaging Analysis (GLAUDIA) Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-90
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 40 and 90 years.
Best-corrected visual acuity ≥ 0.1 LogMAR (≥ 8/10).
IOP ≥ 21 mmHg with normal visual field and/or normal optic nerve head/RNFL, or
Suspicious optic nerve head (excavation), or
Disqualifiers
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).
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to 24 monthsSecondary 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.
Time frame
Baseline to 24 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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