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NCT07210216Not yet recruiting

GLAUcoma Diagnostic and Imaging Analysis (GLAUDIA) Study

New Diagnostic Paradigms for the Identification of Early Glaucomatous Damage

Source: ClinicalTrials.gov · Last updated 7 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
60 (estimated)
First submitted
29 Sept 2025
Start date
1 Oct 2025
Primary completion date
31 Dec 2027
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NCT number
NCT07210216

What you commit to

  • Study type: Observational
  • Planned participants: 60
  • From 1 Oct 2025 to the primary completion date, 31 Dec 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Cognitive impairment reducing test reliability.

Other

  • Best-corrected visual acuity worse than 0.1 LogMAR (\< 8/10).
  • 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.

Who the study is looking for

  • 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).

Age in the registry: 40 years to 90 years · Sex: All

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.