GLAUcoma Diagnostic and Imaging Analysis (GLAUDIA) Study

Not yet recruiting

• Conditions: Glaucoma Open-Angle Primary; Ocular Hypertension

• Registration Number: NCT07210216
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-29
• Study First Submitted QC: 2025-09-29
• Last Update Submitted: 2025-09-29
• Study Start: 2025-10-01
• Study First Posted: 2025-10-07
• Last Update Posted: 2025-10-07
• Primary Completion: 2027-12
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of early glaucomatous damage detected by multimodal imaging	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.

Secondary Outcome Measures

Name	Time	Method
Correlation between OCT structural parameters and visual field indices	Baseline to 24 months	Analysis of the association between RNFL/GCC thickness and visual field MD, PSD, and other indices.