GLAUcoma Diagnostic and Imaging Analysis (GLAUDIA) Study

N/ANot Yet RecruitingNCT07210216

Fondazione Policlinico Universitario Agostino Gemelli IRCCS60 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Glaucoma Open-Angle Primary Ocular Hypertension

Eligibility

Sex: ALLMin age: 40 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 months

Secondary Outcomes

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 months