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NCT Number: NCT07210216

GLAUcoma Diagnostic and Imaging Analysis (GLAUDIA) Study

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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Key information

Conditions

Glaucoma Open-Angle Primary Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Prevalence of early glaucomatous damage detected by multimodal imaging

    Time frame: 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 outcomes

  1. Correlation between OCT structural parameters and visual field indices

    Time frame: Baseline to 24 months

    Analysis of the association between RNFL/GCC thickness and visual field MD, PSD, and other indices.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

New Diagnostic Paradigms for the Identification of Early Glaucomatous Damage

Acronym: GLAUDIA

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 7, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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