Not Yet RecruitingNot Applicable

GLAUcoma Diagnostic and Imaging Analysis (GLAUDIA) Study

60 participantsStarted 2025-10

Plain-language 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 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.

Who can participate

Age range40 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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). Exclusion Criteria: * 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.

What they're measuring

Prevalence of early glaucomatous damage detected by multimodal imaging

Timeframe: Baseline to 24 months

Trial details

NCT IDNCT07210216

SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12