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GLAUcoma Diagnostic and Imagi...

GLAUcoma Diagnostic and Imaging Analysis (GLAUDIA) Study

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-31

Study Completion Date

2028-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Glaucoma Open-Angle Primary Ocular Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers