GLAUcoma Diagnostic and Imaging Analysis (GLAUDIA) Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Glaucoma Open-Angle Primary, Ocular Hypertension. Basic parameters: 40 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
New Diagnostic Paradigms for the Identification of Early Glaucomatous Damage
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.
Primary outcome measures
- Prevalence of early glaucomatous damage detected by multimodal imaging [Time frame: Baseline to 24 months]
Secondary outcome measures (1)
- Correlation between OCT structural parameters and visual field indices [Time frame: Baseline to 24 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07210216 · 6441