Status:
NOT_YET_RECRUITING
GLAUcoma Diagnostic and Imaging Analysis (GLAUDIA) Study
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Glaucoma Open-Angle Primary
Ocular Hypertension
Eligibility:
All Genders
40-90 years
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 hyper...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07210216
Start Date
October 1 2025
End Date
June 1 2028
Last Update
October 7 2025
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